A Phase 1 Study to Evaluate the Safety and Immunogenicity of CDC-9 Inactivated Rotavirus Adjuvanted Vaccine for Intramuscular Administration in Healthy Adults

This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.

开始日期2024-08-05

申办/合作机构

Centers for Disease Control & Prevention

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100 项与 Inactivated Rotavirus Vaccine(Micron Biomedical/Centers for Disease Control and Prevention) 相关的临床结果

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100 项与 Inactivated Rotavirus Vaccine(Micron Biomedical/Centers for Disease Control and Prevention) 相关的转化医学

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100 项与 Inactivated Rotavirus Vaccine(Micron Biomedical/Centers for Disease Control and Prevention) 相关的专利（医药）

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项与 Inactivated Rotavirus Vaccine(Micron Biomedical/Centers for Disease Control and Prevention) 相关的文献（医药）

2022-06-01·Vaccine

Impact of maternal and pre-existing antibodies on immunogenicity of inactivated rotavirus vaccines

Article

作者: Song, Zexin ; Yin, Na ; Zhao, Yongmei ; Lu, Chenxing ; Lin, Xiaochen ; Tang, Yaya ; Wu, Jinyuan ; Zhou, Yan ; Hu, Xiaoqing ; Sun, Maosheng ; Chen, Rong ; Li, Hongjun ; Shi, Peng

Rotavirus (RV) is a major pathogen causing severe diarrhea in infants and children aged less than 5 years. Vaccination is an economically feasible and effective strategy to prevent rotavirus infections. However, immune efficacy of live vaccines could be interfered by maternal antibodies and pre-existing antibodies of children. To develop an inactivated rotavirus vaccine (IRV), we had previously isolated a wild-type human rotavirus strain ZTR-68-A (G1P[8]) from the fecal samples of infants having severe diarrhea in a region endemic for the presence of this pathogen. In our present study, we assessed whether the presence of maternal and pre-existing antibodies in newborn BALB/c mice affected the immunogenicity of IRV administered to these animals. Our results indicate that maternal antibodies, generated from either vaccine immunization or rotavirus infection, showed partial influence with the immune responses generated by two doses of IRV vaccination. Increasing the number of immunizations can significantly improve the titer of serum neutralizing antibody and a seroconversion rate of up to 100%. In newborn mice, single-virus infection did not elicit detectable levels of serum neutralizing antibodies. After an IRV vaccination, the immune responses of these mice remained unaffected, with no significant differences in titers compared with those of control-group mice. In summary, choosing a suitable immunization dose and dosing frequency is essential for the immune effectiveness of IRV. The results of this study will provide animal experimental support for the IRV clinical research in future.

2019-01-02·Human Vaccines & Immunotherapeutics3区 · 医学

Modeling the long-term persistence of neutralizing antibody in children and toddlers after vaccination with live attenuated Japanese encephalitis chimeric virus vaccine

3区 · 医学

Article

作者: Bouckenooghe, Alain ; Bailleux, Fabrice ; Feroldi, Emmanuel

The live-attenuated Japanese encephalitis chimeric virus vaccine JE-CV (IMOJEV®, Sanofi Pasteur) elicits a robust antibody response in children, which wanes over time. Clinical efficacy is based on a correlate of protection against JE infection defined as neutralizing antibody levels equal to or greater than the threshold of 10 (1/dil). Information on the duration of persistence of the JE antibody response above this threshold is needed. We constructed statistical models using 5-year persistence data from a randomised clinical trial (NCT00621764) in children (2-5 years old) primed with inactivated JE vaccine who received a booster dose of JE-CV, and in JE-naïve toddlers (12-24 months) who received a JE-CV single dose primary vaccination. Models were constructed using a Bayesian Monte-Carlo Markov Chain approach and implemented with OpenBugs V3.2.1. Antibody persistence was predicted for up to 10 years following JE-CV vaccination. Findings from a piecewise model with 2 phases (children) and a classic linear model (toddlers) are presented. For children, predicted median antibody titers (77 [2.5th-97.5th percentile range 41-144] 1/dil) remained above the threshold for seroprotection over the 10 years following booster JE-CV vaccination; the predicted median duration of protection was 19.5 years. For toddlers, 10 years after JE-CV primary vaccination median antibody titers were predicted to wane to around the level required for seroprotection (10.8 [5.8-20.1] 1/dil). A booster dose of JE-CV in children is predicted to provide long-term protection against JE. Such data are useful to facilitate decisions on implementation of and recommendations for future vaccination strategies.

2019-01-01·Vaccine3区 · 医学

Lack of immune interference between inactivated polio vaccine and inactivated rotavirus vaccine co-administered by intramuscular injection in two animal species

3区 · 医学

Article

作者: Glass, Roger I ; Jiang, Baoming ; Pisal, S S ; Weldon, William ; Dhere, Rajeev M ; Moon, Sung-Sil ; Wang, Yuhuan ; Zade, Jagdish

A parenteral inactivated rotavirus vaccine (IRV) in development could address three problems with current live oral rotavirus vaccines (ORV): their lower efficacy in low and middle-income countries (LMICs), lingering concerns about their association with intussusception, and their requirement for a separate supply chain with large volume cold storage. Adding a new parenteral IRV to the current schedule of childhood immunizations would be more acceptable if it could be combined with another injectable vaccine such as inactivated polio vaccine (IPV). Current plans for polio eradication call for phasing out oral polio vaccine (OPV) and transitioning to IPV, initially in LMICs as a single dose booster after two doses of OPV and ultimately as a two dose schedule. Today in many LMICs, IPV is administered as a standalone vaccine, which involves a separate cold chain and is relatively costly. We therefore tested in two animal models formulations of IPV with IRV to determine whether co-administration might interfere with the immune response to each product and spare antigen dose for both vaccines. Our results demonstrate that IRV when adjuvanted with alum and administered alone or in combination with IPV did not impair the immune responses to either rotavirus or poliovirus serotypes 1, 2 and 3. Similarly, IPV when formulated and administered alone or together with IRV induced comparable levels of neutralizing antibody to poliovirus type 1, 2 and 3. Furthermore, comparable antibody titers were observed in animals vaccinated with low, middle or high dose of IPV or IRV in combination. This dose sparing and the lack of interference between IPV and IRV administered together represent another step to support the further development of this novel combination vaccine for children.

100 项与 Inactivated Rotavirus Vaccine(Micron Biomedical/Centers for Disease Control and Prevention) 相关的药物交易

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