Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.
Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.

Start Date27 Feb 2024

Sponsor / Collaborator-

NCT06807736

/ RecruitingNot ApplicableIIT

PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.

Start Date13 Feb 2024

Sponsor / Collaborator

Desmond Tutu Hiv Foundation

[+2]

NCT05416021

/ CompletedPhase 1

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

Start Date01 Aug 2022

Sponsor / Collaborator

INC Research Holdings, Inc.

100 Clinical Results associated with Dapivirine

100 Translational Medicine associated with Dapivirine

100 Patents (Medical) associated with Dapivirine

257

Literatures (Medical) associated with Dapivirine

01 Mar 2026·BMJ Global Health

Values and preferences of female sex workers in Zimbabwe for long-acting injectable pre-exposure prophylaxis and the dapivirine vaginal ring: results of a mixed-methods research study

Article

Author: Maguma, Jasper ; Cowan, Frances M ; Baggaley, Rachel ; Machingura, Fortunate ; Rodolph, Michelle ; Chabata, Sungai T ; d'Elbée, Marc ; Kujeke, Tatenda

Introduction:

Female sex workers (FSWs) in sub-Saharan Africa are at high risk of HIV acquisition. Here we explore the values and preferences of Zimbabwean FSW for long-acting pre-exposure prophylaxis (PrEP).

Methods:

We employed mixed methods; focus group discussions (FGD) (n=15), a respondent-driven sampling (RDS) survey (n=4444) from 22 sites across Zimbabwe and a nested discrete choice experiment (DCE) (n=435) conducted in 4/22 sites in 2021. Purposively selected FSWs aged 18 or over who reported being HIV negative were eligible for inclusion in FGDs. Analysis of self-reported HIV negative survey participants was RDS-II weighted. DCE analysis estimated relative preferences. Qualitative and quantitative data were triangulated.

Results:

Median age of survey participants was 28 years with IQR of 23–34 years. There was strong concordance across methods by product, provider, service and individual characteristics. Most FSWs indicated that they preferred long-acting injectable (LAI) PrEP to either oral PrEP or dapivirine vaginal ring (DVR). Most were interested in using LAI PrEP (74.1%; n=1835/2392), a few the DVR (10.9%, n=230/2392), and 2.4% (59/2392) and 13.5% (268/2392) either or neither of the two options, respectively. There was little trust in public sector healthcare providers, with most FSWs opting to access PrEP through programmes designed for sex workers (and stating they would miss a prescription refill/repeat injection if the public sector was the only available option). Injectable PrEP addressed privacy and adherence concerns to some extent, although FSWs felt that 6-monthly would be preferable to less frequent injections. Issues of privacy (related to PrEP and being a FSW), confidentiality and respect emerged as key qualitative themes.

Conclusions:

FSW had a strong preference for LAI PrEP, but ensuring product choice and user privacy was key. FSW in Eastern and Southern Africa should therefore be prioritised for PrEP choices, with ongoing monitoring and evaluation of services to make sure they are acceptable, effective and evolve as products and delivery options become available.

01 Mar 2026·Lancet HIV

Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial

Article

Author: McClure, Tara ; Balkus, Jennifer ; Hillier, Sharon L ; Nakabiito, Clemensia ; Stoner, Marie ; Mgodi, Nyaradzo M ; Mabuza, Carlotta ; Dadabhai, Sufia ; Gadama, Luis ; Piper, Jeanna M ; Chakhtoura, Nahida ; Hawley, Imogen ; Rooney, James F ; Rossi, Lisa ; Mayo, Ashley J ; Anderson, Peter L ; Noguchi, Lisa ; Mhlanga, Felix G ; Chappell, Catherine ; Balan, Ivan ; Kemel, Lena ; Scheckter, Rachel ; Davis, Jontraye ; Livant, Edward ; Fairlie, Lee ; Levy, Lisa ; Song, Mei ; Richardson, Barbra A ; Makanani, Bonus ; Manalo, Maricel ; Fowler, Mary Glenn ; Blanchette, Cheryl ; Musara, Petina ; Katz, Ariana ; Rosenberg, Zeda ; Szydlo, Daniel W ; van der Straten, Ariane ; Cleland, Naana ; Brown, Amanda ; Bunge, Katherine ; Chirenje, Z. Mike ; Singh, Devika ; Duran, Luis ; Young, Alinda ; Taha, Taha E ; Johnson, Abraham ; Beigi, Richard H. ; Harrell, Tanya ; Rausch, Dianne M ; Gous, Hermien ; Montgomery, Elizabeth ; Richardson, Barbra ; Senn, Teri ; Hendrix, Craig ; Gadama, Luis A ; Black, Roberta ; Marzinke, Mark A ; Riddler, Sharon A ; Seyama, Linly

BACKGROUND:

Pregnant women are at a four times higher risk of HIV per coital act than non-pregnant women. MTN-042/DELIVER was a phase 3b randomised study of dapivirine vaginal ring (DVR) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine to assess safety, adherence, and acceptability when used during pregnancy. Our hypothesis was that both DVR and oral PrEP would be safe and well tolerated when started early in the second trimester and continued until delivery.

METHODS:

In MTN-042/DELIVER, an open-label, phase 3b randomised trial, healthy pregnant women without HIV and aged 18-40 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled and randomly allocated (4:1) to open-label monthly DVR PrEP or daily oral PrEP. Women were enrolled between 12 weeks' and 29 weeks' gestation. Product use continued until delivery or 42 weeks' gestation. The primary outcomes for safety following exposure to study product were a composite of all serious adverse events, including maternal deaths, all grade 3 or higher adverse events, and pregnancy outcomes stratified as term (≥37⁺⁰ weeks), preterm (<37⁺⁰ weeks), and pregnancy loss before 20 weeks' gestation. Pregnancy complications and adverse events were summarised with descriptive statistics. This study is registered with ClinicalTrials.gov, NCT03965923.

FINDINGS:

Between July 12, 2022, and Jan 12, 2023, 251 mothers were enrolled, with 202 randomly allocated to receive DVR PrEP and 49 to receive oral PrEP. The median age was 24·0 years (IQR 22·0-29·0) and the median gestational age was 23·7 weeks (19·9-26·3). 28 mothers (11%) had safety events under the composite study primary outcome (all serious adverse events plus all grade 3 or higher adverse events), none of which was related to product use. No maternal deaths or HIV seroconversions occurred. There were 247 pregnancy outcomes of which 233 (94%) were at term (≥37⁺⁰ weeks). Pregnancy complications were uncommon, and none was infectious.

INTERPRETATION:

Adverse pregnancy outcomes related to DVR and oral PrEP use were uncommon among women starting PrEP in the second trimester. These findings support the use of these preventive approaches during pregnancy.

FUNDING:

US National Institutes of Health.

27 Feb 2026·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Response to “Comment on Higher Acceptability of the Monthly Dapivirine Ring Versus Daily Oral Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial”

Article

Author: Friedland, Barbara A. ; Browne, Erica

News (Medical) associated with Dapivirine

22 Apr 2026

·www.cidrz.org

CIDRZ, Ministry of Health Train HIV Specialists in Advanced PrEP Delivery to Strengthen Prevention Efforts.

To strengthen HIV prevention efforts, the Controlling HIV Epidemic Project (CHEP), under the Centre for Infectious Disease Research in Zambia (CIDRZ), in collaboration with the Ministry of Health and with financial support from the United States Department of State, conducted a six-day Training of Trainers (ToT) workshop on the delivery of different pre-exposure prophylaxis (PrEP) products. The training which was held in Ndola, brought together HIV healthcare specialists from CIDRZ, the Copperbelt Provincial Health Office, Ndola Teaching Hospital, Copperbelt District Health Offices, and the United States Department of State. Participants were drawn from Eastern, Western, Lusaka, and Copperbelt provinces. The training was officially opened by Copperbelt Provincial Health Director, Dr Charles Mwinuna, and focused on equipping participants with the skills required to deliver combination HIV prevention services. Particular emphasis was placed on oral PrEP, Cabotegravir (2-month injectable PrEP), Lenacapavir (6-month injectable PrEP), and the Dapivirine Vaginal Ring (DVR), a long-acting, user-controlled PrEP product designed to reduce the risk of acquiring HIV during vaginal sex. Meanwhile, Dr Paul Mwale, Copperbelt Provincial Advanced HIV Disease (AHD) and Injectable PrEP Coordinator under the Ministry of Health, led a session outlining the mandate of the HIV Prevention Programme, which aims to achieve epidemic control and end AIDS by 2030. He highlighted national targets, including reducing new HIV infections from 28,000 to 15,000 by 2026 and increasing PrEP uptake among key and priority populations to 220,000 annually, emphasising the need for accelerated efforts to meet both national and global goals. In another session, Dr Monica Chibesakunda, CIDRZ’s HIV Testing and Prevention Lead, trained participants on HIV testing services, stressing their role in both preventing new infections and linking individuals to care. She emphasised adherence to national HIV testing guidelines for PrEP initiation and the importance of providing tailored prevention services based on individual risk. Other sessions covered demand generation for PrEP, scheduling PrEP clinical visits, managing beneficiaries who missed appointments, switching beneficiaries between PrEP products, pharmacovigilance, and comprehensive data documentation. The training also addressed the link between Gender-Based Violence (GBV), Intimate Partner Violence (IPV), and HIV risk. Facilitators underscored the importance of integrating GBV and IPV screening into HIV services to support comprehensive, client-centred care. The workshop concluded with participants committing to cascade the knowledge gained and strengthen HIV prevention services, contributing to Zambia’s goal of ending AIDS as a public health threat by 2030.

Clinical Study

18 Jan 2023

·pipelinereview.com

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial

Independent, scheduled review of Phase 3 Mosaico study finds investigational vaccine regimen lacks efficacy in preventing HIV No vaccine-related safety issues identified LEIDEN, THE NETHERLANDS I January 18, 2023 I The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified. In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care. “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.” About the Phase 3 Mosaico Study Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States. The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four. The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway. The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile. The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch). Johnson & Johnson’s Commitment to HIV Johnson & Johnson has been committed to the fight against HIV for decades, playing a key role in bringing nine therapeutics to people living with HIV and continuing to drive innovation in HIV prevention and care. In January 2021, the dapivirine ring, a discreet long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021 , Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022 . Additional regulatory decisions are pending. Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic, and has supported collaborative initiatives like the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition , and the New Horizons Collaborative . To learn more about Johnson & Johnson’s commitment to combatting HIV, please visit jnj.com/hiv . About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS . Janssen Vaccines & Prevention, B.V. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. SOURCE: Johnson & Johnson

VaccinePhase 2Phase 3Clinical Result

18 Jan 2023

·www.jnj.com

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial

LEIDEN, THE NETHERLANDS, (January 18, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care.“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”About the Phase 3 Mosaico StudyMosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four.The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway.The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile.The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch).Johnson & Johnson’s Commitment to HIVJohnson & Johnson has been committed to the fight against HIV for decades, playing a key role in bringing nine therapeutics to people living with HIV and continuing to drive innovation in HIV prevention and care.In January 2021, the dapivirine ring, a discreet long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021, Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022. Additional regulatory decisions are pending.Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic, and has supported collaborative initiatives like the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition, and the New Horizons Collaborative.To learn more about Johnson & Johnson’s commitment to combatting HIV, please visit jnj.com/hiv.About Johnson & JohnsonAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Vaccines & Prevention, B.V. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Janssen’s investigational, mosaic-based HIV vaccine regimen. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention, B.V., the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the agreement may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Report on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Vaccines & Prevention, B.V., the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

VaccinePhase 2Phase 3Clinical Result

100 Deals associated with Dapivirine

External Link

KEGG	Wiki	ATC	Drug Bank
D11246	Dapivirine	G01AX17	DB08639

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	Kenya	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Kenya	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	Malawi	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	South Africa	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Zimbabwe	INC Research Holdings, Inc.	01 Jul 2011
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	INC Research Holdings, Inc.	01 Jul 2009
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	International Partnership for Microbicides	01 Jul 2009
Contraception	Phase 1	United States	International Partnership for Microbicides	17 Jul 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	Phase 3	HIV Infections	251	Dapivirine vaginal ring	dbzkqobbnq(npzrfsatwv) = xjgfvszkfv frjfjhpvgr (crhldalsjr ) View more	Positive	01 Mar 2026
NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	Phase 3	HIV Infections	545	Dapivirine vaginal ring	zrqzivuccs(sikkxbrqql) = msvxaerfrs zcvpmuzfyv (lwryuyjgxg ) View more	Positive	01 Nov 2025
				Oral PrEP (tenofovir disoproxil fumarate plus emtricitabine)	zrqzivuccs(sikkxbrqql) = vkokfuxwgp zcvpmuzfyv (lwryuyjgxg ) View more
NCT04140266 (MTN-043, Pubmed \| Lancet HIV)	Phase 3	Breast Feeding	197	Dapivirine vaginal ring (DVR)	dcaahzzgnl(vuepybuyfn) = jqpemcujik gjmpamnwcf (mrwdhzygqb )	Positive	01 Mar 2025
NCT01617096 (MTN-020/ASPIRE, Pubmed \| J Infect Dis)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring	fchknvsxuw(ikvvttyejn) = rwhxszbrfm yezcqqcjqs (ihjouhujku, 1.8 - 3.1)	Positive	12 Apr 2024
				Placebo	fchknvsxuw(ikvvttyejn) = wrzprrkcoi yezcqqcjqs (ihjouhujku, 2.9 - 4.4)
NCT01539226 (The Ring Study, Pubmed \| BMJ Open) Manual	Not Applicable	HIV Infections	197	Dapivirine vaginal ring / placebo vaginal ring	ynglkzlele(ifydblxiey) = lkllsaghxl vsonzckymz (gliajbkvcv, 44.7 - 60.3) View more	Negative	08 Apr 2024
				Dapivirine vaginal ring	ynglkzlele(ifydblxiey) = oukoryrxtl vsonzckymz (gliajbkvcv )
NCT01617096 (MTN-020/ASPIRE \| ASPIRE \| MTN-020, CTgov)	Phase 3	HIV Infections	2,629	Dapivirine Vaginal Ring (Dapivirine Vaginal Ring)	zxvdrqpxex = xeakbnadkz clvbabqldi (xlzfrwwnbk, clyayclwda - inhsrfgikb) View more	-	16 Dec 2022
				Placebo Ring (Placebo Ring)	zxvdrqpxex = eosbkoykgf clvbabqldi (xlzfrwwnbk, wmnolaagfr - qgssgytkqh) View more
NCT02862171 \| NCT01539226 (The Ring Study and DREAM, Pubmed)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring-004 (DVR)	yxbkbqwfsk(kiyliczjrc) = qddcygwalm vmqhhlbxew (wegjuqikkr )	-	08 Nov 2022
NCT02862171 (DREAM, CTgov)	Phase 3	HIV Infections	941	Dapivirine Vaginal Ring-004	mtqwnjsjci = ihgvpjtojc mioetxequm (hbwkxnpvub, bmcbmfscam - ppexbxtwge) View more	-	25 Oct 2022
NCT00799058 (CTgov)	Phase 1/2	HIV Infections	128	dapivirine gel 4759 (Dapivirine Gel 4759)	cibhkqltrd = kcpsgnnghm eqnsyalfix (kdpqewqhbh, poyrrailod - uyljgadwee) View more	-	25 Oct 2022
				dapivirine 4789 (Dapivirine Gel 4789)	cibhkqltrd = shotpftrlx eqnsyalfix (kdpqewqhbh, vtgnxfdtgo - ixqrppgdxm) View more
NCT02858037 (HOPE, CTgov)	Phase 3	HIV Infections	1,456	Dapivirine Vaginal Ring	qodowrmazz = gnhhbimgku nydtktwbxl (uxhbyftriy, mlcxkcmsjb - msnhfpehvl) View more	-	25 Oct 2022

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