A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

Start Date20 Mar 2024

Sponsor / Collaborator

AIM Vaccine Co., Ltd.

NCT05939648 / Active, not recruitingPhase 2

Randomized, Blinded, Positive and Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Booster Vaccination in People 18 Years of Age and Older Who Have Received SARS-CoV-2 Vaccine.

This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.

Start Date09 Oct 2023

Sponsor / Collaborator

AIM Vaccine Co., Ltd.

[+1]

NCT06044077 / RecruitingPhase 3

A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above

This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.

Start Date08 Sep 2023

Sponsor / Collaborator

Zhejiang Weixin Biological Pharmaceutical Co. Ltd.

100 Clinical Results associated with AIM Vaccine Co., Ltd.

0 Patents (Medical) associated with AIM Vaccine Co., Ltd.

Literatures (Medical) associated with AIM Vaccine Co., Ltd.

01 Nov 2023·Vaccine

Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults

Article

Author: Jiang, Guo-Ping ; Dai, Xia-Hong ; Wu, Kai-Qi ; Wu, Xiao-Hong ; Jin, Ting-Han ; Gao, Hai-Nv ; Liu, Qi ; Yu, Xu-Ya ; Luo, Li-Ping ; Pei, Rong-Juan ; Zhong-Chen ; Peng, Yu-Cai ; Shao, Xi ; Shen, Zhen-Wei ; Lou, Dan-Feng ; Li, Lan-Juan ; He, Jian-Xing ; Li, Yu-Hua ; Jiang, Qi ; Huang, Yu-Mei ; Zhang, Fan ; Li, Nan ; Peng, Cong-Gao ; Deng, Fei ; Cao, Fang ; Zhu, Jing-Rui ; Guo, Tong ; Chen, Gui-Ling

BACKGROUNDCOVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in China of an mRNA vaccine (LVRNA009).METHODSIn the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.RESULTSAll these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.CONCLUSIONLVRNA009 has demonstrated promising results in safety and tolerability at all three dose levels among Chinese adults. LVRNA009 at three dose levels could rapidly induce strong humoral and cellular immune responses, including binding and neutralising antibody production and IFN- γ secretion, which showed good immunogenicity.CLINICAL TRIAL REGISTRATION NUMBERClinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.

01 Jan 2017·VirologyQ3 · MEDICINE

Pathologic and immunologic characteristics of coxsackievirus A16 infection in rhesus macaques

Q3 · MEDICINE

Article

Author: Guo, Lei ; Liu, Longding ; Che, Yanchun ; Lu, Shuaiyao ; Zhang, Ying ; Wang, Lichun ; He, Zhanlong ; Wang, Jingjing ; Liao, Yun ; Pu, Jing ; Dong, Chenghong ; Feng, Min ; Hu, Yajie ; Liang, Yan ; Wang, Xi ; Li, Yanyan ; Yang, Erxia ; Li, Qihan ; Jiang, Li ; Fan, Shengtao ; Song, Jie ; Zhang, Xiaolong ; Zhao, Ting

Coxsackievirus A16 (CV-A16) causes human hand, foot and mouth disease, but its pathogenesis is unclear. In rhesus macaques, CV-A16 infection causes characteristic vesicles in the oral mucosa and limbs as well as viremia and positive viral loads in the tissues, suggesting that these animals reflect the pathologic process of the infection. An immunologic analysis indicated a defective immune response, which included undetectable neutralizing antibodies and IFN-γ-specific memory T-cells in macaques infected with CV-A16. Furthermore, existing neutralizing antibodies in macaques immunized with the inactivated vaccine were surprisingly unable to protect against a viral challenge despite the presence of a positive T-cell memory response against viral antigens. The virus was capable of infecting pre-conventional dendritic cells and replicating within them, which may correlate with the immunological characteristics observed in the animals.

01 Dec 2015·BMC MedicineQ1 · MEDICINE

Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations

Q1 · MEDICINE

ArticleOA

Author: Yang, Erxia ; Huang, Teng ; Mo, Zhaojun ; Tan, Soon Hao ; Liao, Yun ; Mao, Qunying ; Cui, Pingfang ; Shi, Haijing ; Guo, Lei ; Zhao, Hongling ; Xia, Jielai ; David, Perera ; Dong, Chenghong ; Che, Yanchun ; Wong, Kum Thong ; Li, Rongcheng ; Liu, Longding ; Ong, Kien Chai ; Feng, Min ; Li, Qihan ; Cui, Wei ; Wang, Xuanyi ; Xie, Zhongping ; Na, Ruixiong ; Liang, Zhenglun ; Pu, Jing ; Zhang, Ying ; Wang, Ling ; Wang, Junzhi ; Wang, Lichun ; Liang, Yan ; Jiang, Li ; Wang, Jingjing ; Zhou, Zhenxin

BACKGROUNDTo investigate the long-term effects on immunity of an inactivated enterovirus 71 (EV71) vaccine and its protective efficacy.METHODSA sub-cohort of 1,100 volunteers from Guangxi Province in China was eligible for enrolment and randomly administered either the EV71 vaccine or a placebo on days 0 and 28 in a phase III clinical trial and then observed for the following 2 years with approval by an independent ethics committee of Guangxi Zhuang Autonomous Region, China. Serum samples from the 350 participants who provided a full series of blood samples (at all the sampling points) within the 2-year period were collected. Vaccine-induced immune effects, including the neutralizing antibody titres and cross-protection against different genotypes of EV71, were examined. This study also evaluated the protective efficacy of this vaccine based upon clinical diagnosis.RESULTSThis sub-cohort showed a >60% drop-out rate over 2 years. The seroconversion rates among the 161 immunized subjects remained >95% at the end of study. The geometric mean titres of neutralizing antibodies (anti-genotype C4) 360 days after vaccination in 350 subjects were 81.0 (subjects aged 6-11 months), 98.4 (12-23 months), 95.0 (24-35 months), and 81.8 (36-71 months). These titres subsequently increased to 423.1, 659.0, 545.0, and 321.9, respectively, at 540 days post-immunization (d.p.i.), and similar levels were maintained at 720 d.p.i. Higher IFN-γ/IL-4-specific responses to the C4 genotype of EV71 and cross-neutralization reactivity against major EV71 genotype strains were observed in the vaccine group compared to those in the placebo group. Five EV71-infected subjects were observed in the placebo-treated control group and none in the vaccine-immunized group in per-protocol analysis.CONCLUSIONThese results are consistent with the induction of dynamic immune responses and protective efficacy of the vaccine against most circulating EV71 strains.TRIAL REGISTRATION NUMBERClinicaltrials.gov, NCT01569581, Trial registration date: March 2012.

News (Medical) associated with AIM Vaccine Co., Ltd.

07 Dec 2023

·www.prnewswire.com

Spartan Capital Securities, LLC Successfully Closes $69 Million IPO

The SPAC Deal for Aimei Health Technology Co., LTD is Spartan's 12th closed Initial Public Offering in 2023 NEW YORK, Dec. 7, 2023 /PRNewswire/ -- Spartan Capital Securities, LLC has defied the current IPO markets again, successfully closing an end of the year Initial Public Offering for Aimei Health Technology Co., LTD, a start-up specializing in the biopharmaceutical, medical technology, medical device, and diagnostics spaces. Continue Reading Spartan acted as sole book running manager for the offering, pricing Aimei at $10.00 a Unit with a total offering of $69 million on the Nasdaq including the overallotment option of an additional 900,000 Units at the time of closing, which Spartan exercised. As a result, the aggregate gross value of the IPO was $69 million, making it Spartan's largest IPO of the year. Spartan Capital Securities, LLC closes its 12th IPO in 2023 for $69 million, its largest of the year Post this Aimei's successful IPO and Spartan's sole underwriting role are notable not simply because of the deal's size, but also because it has occurred despite the current IPO market. Raising capital has been extremely difficult for companies across the board this year. As a result, 2023 has been one of the slowest for IPOs in recent memory. "The global IPO market has been like Game Of Thrones post pandemic: winter is coming, and it's been long," says Spartan Capital Securities' founder and CEO, John Lowry. "There are a lot promises. Banks and Bankers are signing deals. But it's been really hard for companies to raise money and even when the offering happens many of them haven't been able to close. We've been fortunate at Spartan and have been able to navigate this frozen market, spot the right companies and opportunities, and actually get several deals done. The Aimei IPO allows us to close a good year out on a great note. It's also a positive indicator for 2024 that the markets are starting to thaw and that we seem to be getting back to business as usual." Year to date, Spartan has closed 51 transactions and 12 IPOs for a total value of $679 million in capital raised. While less than a third of the value Spartan would do in a strong market at a similar pace, it's still far more than most similarly sized investment banks have raised this year. "There's also over three weeks remaining until New Year's Eve," adds Lowry, "We're still pushing a few other deals along and hoping to get that number closer to a billion." MEDIA CONTACT: Marcela Rubio Ortiz PR Kitchen [email protected] SOURCE Spartan Capital Securities, LLC

IPO

100 Deals associated with AIM Vaccine Co., Ltd.

100 Translational Medicine associated with AIM Vaccine Co., Ltd.

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Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Rabies Vaccine for Human Use(Ningbo Rongan Biological Pharmaceutical Co Ltd)	Rabies More	Approved
Rabies vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)	Rabies More	Approved
Hepatitis A vaccine (human diploid cell),inactivated(Jiangsu Convac Biology Technical Co Ltd)	Hepatitis A More	Approved
Mumps Vaccine, Live(Zhejiang Vacin Biomedicine Ltd)	Parotitis More	Approved
Influenza vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)	Influenza, Human More	Approved

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