Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.

Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.

Start Date07 Oct 2011

Sponsor / Collaborator

University of Oxford

[+2]

NCT00679172 / CompletedPhase 2

A Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study to Determine the Immunogenicity, Safety and Tolerability of S. Typhi (Ty2 aroC-ssaV-) ZH9 at Doses of 5.0 x 10E9 CFU, 7.5 x 10E9 CFU, 1.1 x 10E10 and 1.7 x 10E10 CFU and 1.7 x 10E10 CFU, Following Oral Administration to Healthy, Typhoid Vaccine naïve Subjects in the USA.

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

Start Date01 May 2008

Sponsor / Collaborator

Emergent BioSolutions, Inc.

100 Clinical Results associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

100 Translational Medicine associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

100 Patents (Medical) associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

Literatures (Medical) associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

01 Dec 2024·VACCINE

Fatal ascending paralysis after typhoid vaccine: Guillain and Barré's description of the very first case

Article

Author: Wijdicks, Eelco F.M. ; Wijdicks, Eelco F M

BACKGROUND:

Albeit rare, Guillain - Barré syndrome (GBS) has been associated with several vaccines. Surveys of these associations have not looked before 1950. Herein, I revisit the first described case of vaccine-associated GBS, manifesting during the Great War and to prevent typhoid.

METHODS:

Review of primary and secondary source material. Description of a landmark case.

RESULTS:

Review of a report of a 31-year-old brigadier who was revaccinated with "vaccin TAB" (a triple antityphoid-paratyphoid vaccine A and B) which days later was followed by rapid progression of limb weakness, oropharyngeal weakness and fatal neuromuscular respiratory weakness. Cerebrospinal fluid showed mild pleocytosis and increased protein (albumen). There was a normal brain and spinal cord at autopsy.

CONCLUSION:

This is the first reported case of a vaccine-associated GBS.

01 Nov 2024·Lancet Global Health

The effect of BCG revaccination on the response to unrelated vaccines in urban Ugandan adolescents (POPVAC C): an open-label, randomised controlled trial

Article

Author: Serubanja, Joel ; van Dam, Govert J ; Webb, Emily L ; Kakande, Ayoub ; Kaleebu, Pontiano ; Natukunda, Agnes ; Kabali, Joel ; Zirimenya, Ludoviko ; Nassuuna, Jacent ; Kabagenyi, Joyce ; Kukundakwe, Christine ; Kiwudhu, Fred ; Nkurunungi, Gyaviira ; Namusobya, Loyce ; Oduru, Gloria ; Mutebe, Alex ; Apule, Barbara ; Kabuubi, Prossy N ; Sewankambo, Moses ; Akello, Florence A ; Kizindo, Robert ; Katushabe, Charity ; Ninsiima, Caroline ; Kizza, Moses ; Walusimbi, Bridgious ; Nayebare, Doreen ; Akello, Mirriam ; Akurut, Hellen ; Elliott, Alison M ; Kiwanuka, Samuel ; Nkangi, Ronald ; Nassanga, Beatrice ; Driciru, Emmanuella ; Kayiwa, John ; Wajja, Anne ; Nankabirwa, Christine ; Onen, Caroline ; Namutebi, Milly ; Amongi, Susan ; Cose, Stephen ; Kabami, Grace ; Nyanzi, Ruth ; Amongin, Rebecca ; Tumusiime, Josephine ; Zziwa, Christopher ; Nakazibwe, Esther ; Tumwesige, Pius ; Nsubuga, Denis ; Corstjens, Paul L A M

BACKGROUND:

Immune responses induced by several important vaccines differ between populations, with reduced responses in low-income and rural settings compared with high-income and urban settings. BCG immunisation boosts immune responses to some unrelated vaccines in high-income populations. We aimed to test the hypothesis that BCG revaccination can enhance responses to unrelated vaccines in Ugandan schoolchildren.

METHODS:

We conducted an open-label, randomised controlled trial to compare the effects of BCG revaccination versus no BCG revaccination on the immunogenicity of subsequent unrelated vaccines among adolescents aged 13-17 years who are participants in an urban Ugandan birth cohort study, in which BCG vaccination was documented at birth. Participants were excluded if they had received any of the trial vaccines or related agents when aged 5 years or older. Computer-generated 1:1 randomisation was implemented in REDCap. Participants were excluded if they were concurrently enrolled in other trials; had a clinically significant history of immunodeficiency, or serious psychiatric conditions or moderate to severe acute illnesses; were taking immunosuppressive medications; had allergies to vaccine components, a predisposition towards developing keloid scarring; positive HIV tests or pregnancy tests; were female participants who were lactating; or if they planned to use investigational drugs, vaccines, blood products, or any combination thereof. Trial participants assigned to the BCG revaccination group received the live parenteral BCG-Russia vaccine (Serum Institute of India, Pune, India; 0·1 mL intradermally, right upper arm) at week 0. All participants received yellow fever vaccine (YF-17D; Sanofi Pasteur, Lyon, France; 0·5 mL intramuscularly, left upper arm), live oral typhoid vaccine (Ty21a; PaxVax, London, UK; one capsule per day taken for three alternate days), and quadrivalent virus-like particle human papillomavirus (HPV) vaccine (Merck, Rahway, NJ, USA; 0·5 mL intramuscularly, left upper arm) at week 4; and toxoid vaccines (tetanus-diphtheria; Serum Institute of India; 0·5 mL intramuscularly, left upper arm) and an HPV booster at week 28. An additional HPV vaccination at week 8 was provided to female participants older than 14 years who had not previously been vaccinated. The primary outcomes were yellow fever neutralising antibody titres at 4 weeks post-YF-17D vaccination, Salmonella enterica serovar Typhi (henceforth S Typhi) O-lipopolysaccharide (O:LPS)-specific IgG concentration at 4 weeks post-Ty21a vaccination, and HPV-16 and HPV-18 L1 protein-specific IgG concentration at 4 weeks post-HPV vaccination. Primary outcome assays were conducted at week 8, and at week 52 for tetanus-diphtheria. We conducted an intention-to-treat analysis comparing log-transformed outcomes between trial groups, with results back-transformed to geometric mean ratios (GMRs). The safety population comprised all randomly allocated participants. The trial was registered at the ISRCTN Registry (ISRCTN10482904) and is complete.

FINDINGS:

Between Aug 31 and Oct 12, 2020, we screened 376 potential participants for eligibility. We enrolled and randomly allocated 300 participants to the two groups (151 [50%] to the BCG group and 149 [50%] to the no BCG group). 178 (59%) of 300 participants were male and 122 (41%) were female. 142 (91%) of 151 participants in the BCG group and 139 (93%) of 149 in the no BCG group completed follow-up. There was no effect of BCG revaccination, compared with no BCG revaccination, on the response observed for any vaccine. Yellow fever plaque reduction neutralising reference tests (PRNT₅₀) titres (the reciprocal of the last plasma dilution that reduced by 50%) had a GMR of 0·95 (95% CI 0·75-1·19; p=0·62) and PRNT₉₀ (reciprocal of the last plasma dilution that reduced by 90%) had a GMR of 0·94 (0·74-1·19; p=0·60); IgG to S Typhi O:LPS was 0·99 (0·80-1·23; p=0·94); IgG to HPV-16 was 0·97 (0·69-1·35; p=0·85) and to HPV-18 was 1·03 (0·76-1·40; p=0·83); and toxoid-specific IgG for tetanus was 1·13 (0·87-1·47; p=0·36) and was 1·00 (0·87-1·16; p=0·97) for diphtheria. There were no serious adverse events in either group.

INTERPRETATION:

We found no evidence that BCG revaccination is an effective strategy to improve immunogenicity of other vaccines in this low-income, urban setting.

FUNDING:

UK Medical Research Council.

TRANSLATION:

For the Luganda translation of the abstract see Supplementary Materials section.

01 Nov 2024·Lancet Global Health

The effect of intermittent preventive treatment for malaria with dihydroartemisinin–piperaquine on vaccine-specific responses among schoolchildren in rural Uganda (POPVAC B): a double-blind, randomised controlled trial

Article

Author: Akello, Florence A ; Webb, Emily L ; van Dam, Govert J ; Oduru, Gloria ; Kakande, Ayoub ; Amongin, Rebecca ; Katushabe, Charity ; Kaleebu, Pontiano ; Natukunda, Agnes ; Nassuuna, Jacent ; Nkurunungi, Gyaviira ; Kiwudhu, Fred ; Zirimenya, Ludoviko ; Kabagenyi, Joyce ; Nsubuga, Denis ; Kabuubi, Prossy N ; Namusobya, Loyce ; Namusobya, Loyce K ; Mutebe, Alex ; Staedke, Sarah G ; Nankabirwa, Christine M ; Kabali, Joel ; Sewankambo, Moses ; Kizindo, Robert ; Ninsiima, Caroline ; Tumusiime, Josephine ; Kizza, Moses ; Nayebare, Doreen ; Elliott, Alison M ; Akello, Mirriam ; Kiwanuka, Samuel ; Nkangi, Ronald ; Akurut, Hellen ; Kabami, Grace ; Nassanga, Beatrice ; Wajja, Anne ; Kayiwa, John ; Apule, Barbara ; Nankabirwa, Christine ; Namutebi, Milly ; Kukundakwe, Christine ; Walusimbi, Bridgious ; Driciru, Emmanuella ; Cose, Stephen ; Nyanzi, Ruth ; Serubanja, Joel ; Amongi, Susan ; Onen, Caroline ; Zziwa, Christopher ; Tumwesige, Pius ; Nakazibwe, Esther ; Corstjens, Paul L A M

BACKGROUND:

Several important vaccines differ in immunogenicity and efficacy between populations. We hypothesised that malaria suppresses responses to unrelated vaccines and that this effect can be reversed-at least partially-by monthly malaria intermittent preventive treatment (IPT) in high-transmission settings.

METHODS:

We conducted an individually randomised, double-blind, placebo-controlled trial of the effect of malaria IPT with dihydroartemisinin-piperaquine on vaccine responses among schoolchildren aged 9-17 years in Jinja district, Uganda. Participants were recruited from two schools and did not have exposure to vaccines of interest after the age of 5 years, with the exception of human papillomavirus (HPV). Computer-generated 1:1 randomisation was implemented in REDCap. 3-day courses of dihydroartemisinin-piperaquine (dosage by weight) or placebo were administered monthly, including twice before the first vaccination. Trial participants were vaccinated with the live parenteral BCG vaccine (Serum Institute of India, Pune, India) at week 0; yellow fever vaccine (YF-17D; Sanofi Pasteur, Lyon, France); live oral typhoid vaccine (Ty21a; PaxVax, London, UK), and quadrivalent virus-like particle HPV vaccine (Merck, Rahway, NJ, USA) at week 4; and toxoid vaccines (tetanus-diphtheria; Serum Institute of India) and an HPV booster at week 28. An additional HPV vaccination at week 8 was provided to female participants older than 14 years who had not previously been vaccinated, and a tetanus-diphtheria booster was given after completion of the trial at week 52. Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, at week 52, and analysis was done in the intention-to-treat population. Malaria parasite prevalence at enrolment and during follow-up was determined retrospectively by PCR. The safety population comprised all randomly allocated participants. The trial was registered at the ISRCTN Registry (ISRCTN62041885) and is complete.

FINDINGS:

Between May 25 and July 14, 2021, we assessed 388 potential participants for eligibility. We enrolled and randomly allocated 341 participants to the two groups (170 [50%] to dihydroartemisinin-piperaquine and 171 [50%] to placebo); 192 (56%) were female and 149 (44%) participants were male. 145 (85%) participants in the dihydroartemisinin-piperaquine group and 140 participants (82%) in the placebo group were followed up until the week 52 endpoint. At enrolment, 109 (64%) of all participants in the dihydroartemisinin-piperaquine group and 99 (58%) of 170 participants in the placebo group had malaria; this reduced to 6% or lower at all follow-up visits in the dihydroartemisinin-piperaquine group. There was no effect of dihydroartemisinin-piperaquine versus placebo on primary outcomes: BCG-specific IFNγ ELISpot response had a geometric mean ratio (GMR) of 1·09 (95% CI 0·93-1·29), p=0·28; yellow fever neutralising antibody was 1·19 (0·91-1·54), p=0·20 for plaque reduction neutralising reference tests (PRNT₅₀) titres (the reciprocal of the last plasma dilution that reduced by 50%) and 1·24 (0·97-1·58), p=0·09 for PRNT₉₀ titres (reciprocal of the last plasma dilution that reduced by 90%); and IgG to Salmonella enterica serovar Typhi O-lipopolysaccharide was 1·09 (0·81-1·46), p=0·58, HPV-16 was 0·72 (0·44-1·77), p=0·19, HPV-18 was 0·71 (0·47-1·09), p=0·11; tetanus toxoid was 1·22 (0·91-1·62), p=0·18, and diphtheria toxoid was 0·97 (0·83-1·13), p=0·72. There was some evidence that dihydroartemisinin-piperaquine reduced waning of the yellow fever response.

INTERPRETATION:

IPT for malaria with dihydroartemisinin-piperaquine did not improve peak vaccine responses, despite reducing malaria prevalence. Possible longer-term effects on response waning should be further explored.

FUNDING:

UK Medical Research Council.

TRANSLATION:

For the Luganda translation of the abstract see Supplementary Materials section.

News (Medical) associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

26 Feb 2024

·www.pharmaceutical-technology.com

SK bioscience’s typhoid vaccine receives WHO prequalification

SK bioscience developed the SKYTyphoid vaccine along with the International Vaccine Institute (IVI). Credit: SK bioscience. SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving prequalification (PQ) certification from the World Health Organization (WHO). This is the fourth WHO PQ for the company, following certifications for two influenza vaccines and a varicella vaccine. The WHO PQ system is a rigorous process that ensures the safety and efficacy of vaccines by assessing their manufacturing process, quality and clinical trial data. The development of SKYTyphoid was a collaborative effort with the International Vaccine Institute (IVI) and received support from the Bill & Melinda Gates Foundation. SKYTyphoid employs the purified Vi polysaccharide-diphtheria toxoid conjugate method, which is safe for infants and children aged six months to two years. See Also: Neurocrine Biosciences sees highest patent filings and grants during December in Q4 2023 Caribou Biosciences sees highest patent filings and grants during November in Q4 2023 It provides comparable immunogenicity and long-term protection with a single dose, as against current oral live or polysaccharide typhoid vaccines. In 2022, SKYTyphoid obtained an export licence from the Korean Ministry of Food and Drug Safety, following a global clinical trial. The Phase III study involved 2,160 subjects aged six months to 45 years in Nepal, showcasing a favourable immunogenicity and safety profile. The results indicated that SKYTyphoid’s performance was on par with another WHO PQ-certified polysaccharide-protein conjugate typhoid vaccine. SK bioscience CEO Jaeyong Ahn stated: “We are pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognised by the WHO PQ certification. “We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries.” With the WHO PQ designation, SK bioscience is set to target global markets, focusing on public procurement in typhoid-endemic countries with high demand. IVI director general Dr Jerome Kim stated: “Typhoid fever is more prevalent in warmer temperatures, and climate change and the worrying rise of antimicrobial resistance are only adding to the threat of the disease. Vaccination is critical to effective prevention and control of the disease. In collaboration with SK bioscience and other partners, IVI will continue endeavours to make this vaccine accessible to people who need it the most.”

VaccinePhase 3Clinical Result

23 Feb 2024

·www.prnewswire.com

SK bioscience Receives WHO Prequalification for Typhoid Conjugate Vaccine

SKYTyphoid is jointly developed with the International Vaccine Institute, supported by the Bill & Melinda Gates Foundation. WHO PQ paves the way for public procurement by UN organizations. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. SEONGNAM, South Korea, Feb. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), 'SKYTyphoid®' (project name NBP618). This the fourth WHO PQ the company has received following its two influenza vaccines and varicella vaccine. Continue Reading SK bioscience receives WHO prequalification for typhoid conjugate caccine. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. The WHO PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria to certify its safety and efficacy. The tested vaccine must comply with stringent procedures, including: examination of technical documents, including clinical and quality data, testing of sample quality, inspection of manufacturing facilities to ensure adherence to Good Manufacturing Practices (GMP) and quality control standards. SKYTyphoid was jointly developed with the International Vaccine Institute (IVI) and is supported by the Bill & Melinda Gates Foundation. This vaccine utilizes the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method, which conjugates a polysaccharide of typhoid bacteria, serving as an antigen, to a diphtheria toxin protein (diphtheria toxoid), that acts as a carrier. Utilizing this conjugate technology, the vaccine can be safely administered to infants and children aged 6 months to 2 years. It is anticipated to offer comparable immunogenicity and long-term protection with a single dose, compared to existing oral live or polysaccharide typhoid vaccines. SKYTyphoid has received an export license from the Korean Ministry of Food and Drug Safety in 2022, based on the results of a global clinical study. The Phase III study, which enrolled 2,160 participants ranging from toddlers aged 6 months to individuals aged 45 years in Nepal, demonstrated a positive immunogenicity and safety profile of SKYTyphoid. Compared to the existing polysaccharide-protein conjugate typhoid vaccine with WHO PQ certification, SKYTyphoid showed comparable immunogenicity and safety profile across all age groups. These findings were published in The Lancet Infectious Disease, a sister journal to Lancet[1]. With WHO PQ, SK bioscience plans to target global markets with SKYTyphoid, focusing on public procurement markets, including major typhoid-endemic countries with high demands. According to the WHO, there are between 11 to 20 million typhoid fever cases reported worldwide each year, resulting in approximately 120,000 to 160,000 deaths. Jaeyong Ahn, CEO of SK bioscience, said, "We are pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognized by the WHO PQ certification," adding, "We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries." Dr. Jerome Kim, Director General of IVI said, "Typhoid fever is more prevalent in warmer temperatures, and climate change and the worrying rise of antimicrobial resistance are only adding to the threat of the disease. Vaccination is critical to effective prevention and control of the disease. In collaboration with SK bioscience and other partners, IVI will continue endeavors to make this vaccine accessible to people who need it the most." About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed in vaccine development and manufacturing to enable more equitable access of vaccines in the world. In leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) SOURCE SK bioscience

VaccineClinical ResultPhase 3Emergency Use Authorization

15 Feb 2024

·www.sciencedaily.com

Environmental monitoring offers low-cost tool for typhoid fever surveillance

Researchers can accurately track where typhoid fever cases are highest by monitoring environmental samples for viruses called bacteriophages that specifically infect the bacterium that causes typhoid fever. Researchers can accurately track where typhoid fever cases are highest by monitoring environmental samples for viruses called bacteriophages that specifically infect the bacterium that causes typhoid fever. Senjuti Saha of the Child Health Research Foundation in Bangladesh and colleagues report these findings in a new study published February 15 in the open access journal PLOS Neglected Tropical Diseases. Typhoid fever is a common infection in many low- and middle-income countries and causes an estimated 135,000 deaths and 14 million infections globally each year. The World Health Organization has prequalified two typhoid vaccines, but for policymakers to plan effective vaccination strategies, they need accurate, high-resolution estimates of where the burden is highest. Traditionally, people have cultured the bacterium that causes typhoid fever from blood samples to determine where the infection is most common, but in the new paper, researchers tried a more cost-effective surveillance approach. They tested environmental water samples from sewage and other locations to detect bacteriophages specific to the water-borne pathogen that causes typhoid fever, Salmonella Typhi. The team tested 303 water samples from two locations in Bangladesh: the urban capital city, Dhaka, and a rural district, Mirzapur. They found that bacteriophages specific for Salmonella Typhi were present in 31% of environmental samples in Dhaka, compared to just 3% of samples from Mirzapur. This corresponds to results from more than 8,400 blood cultures, in which 5% of cultures from Dhaka and 0.05% from Mirzapur tested positive. The new results suggest that detecting bacteriophages specific for Salmonella Typhi may be a rapid environmental surveillance method that could help decision makers understand the presence of typhoid fever in the community. The researchers propose that environment monitoring of bacteriophage could be a simple, cost-effective and scalable tool to assist policy decisions on typhoid control. The authors add: ""Looking for bacteriophages in wastewater is a low-cost method for identifying typhoid hotspots without doing expensive blood cultures on thousands of people."

VaccineClinical ResultClinical Study

100 Deals associated with Typhoid vaccine(Emergent BioSolutions, Inc.)

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Indication	Highest Phase	Country/Location	Organization	Date
Typhoid Fever	Phase 2	US	Emergent BioSolutions, Inc.	01 May 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00679172 (CTgov)	Phase 2	Typhoid Fever	187	Placebo (Cohorts 1-4 pooled)+Dose of 5.0 x 10^9 CFU (Cohort 1) (M01ZH09 Vaccine Candidate Cohort 1)	gtltbptlsq(toxsnblcdh) = vtasfovehu fpplucjbiy (okodemkwjz, tomresnrdy - gvvxadyorx) View more	-	07 Jun 2017
				Placebo (Cohorts 1-4 pooled)+Dose of 7.5 x 10^9 CFU (Cohort 2) (M01ZH09 Vaccine Candidate Cohort 2)	gtltbptlsq(toxsnblcdh) = cygrngsphw fpplucjbiy (okodemkwjz, wtjghiogmf - apctwcojts) View more
NCT01405521 (Pubmed \| PLoS Negl Trop Dis)	Phase 2	-	99	M01ZH09	mqmibkqiul(tehygpoefl) = uokquvmute bkbhockopz (cizpdpmnxu, 39.1 - 75.5) View more	Negative	01 Aug 2016
				Placebo	mqmibkqiul(tehygpoefl) = uyipabzejf bkbhockopz (cizpdpmnxu, 47.2 - 87.2)
NCT00679172 (Pubmed \| Vaccine)	Phase 2	Typhoid Fever	187	M01ZH09	clzzqxpbpr(cnyvkkilhf) = One subject had a transient low-grade fever heeimbzrmw (avrxrprsao )	-	30 Apr 2010

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