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Also known as Heat Stable Rotavirus (HSRV) Vaccine
Heat Stable Rotavirus Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Heat Stable Rotavirus (HSRV) Vaccine | EXPERIMENTAL | 25 healthy adults who will be administered a single dose of test HSRV vaccine |
| Placebo for Heatstable Rotavirus vaccine | PLACEBO_COMPARATOR | 25 healthy adults who will be administered a single dose of placebo |
| Heat Stable Rotavirus Vaccine | EXPERIMENTAL | 25 healthy infants who will be administered 3-doses of test HSRV vaccine spaced at 4-week intervals |
| RotaTeq | ACTIVE_COMPARATOR | 25 healthy infants who will be administered 3-doses of comparator Rotateq® vaccine spaced at 4-week intervals |
| Name | Type | Description |
|---|---|---|
| Heat Stable Rotavirus (HSRV) Vaccine | BIOLOGICAL | It is a lyophilized live attenuated pentavalent (G1-G4 and P1\[8\]) heat-stable rotavirus vaccine (HSRV) comprising of all the five rotavirus strains as in licensed RotaTeq® vaccine for protection against rotavirus infection |
| Placebo for Heatstable Rotavirus vaccine | BIOLOGICAL | It is a lyophilized formulation comprising of all the inactive ingredients as in heat stable rotavirus vaccine without any rotavirus |
| RotaTeq® | BIOLOGICAL | It is a pentavalent human-bovine (WC3) reassortant live-attenuated, oral vaccine developed by Merck Research Co., West Point, Pennsylvania, USA. This vaccine contains five live reassortant rotaviruses. Four reassortant rotaviruses express the VP7 protein (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7\[5\]) from bovine rotavirus parent strain WC3. The fifth reassortant virus expresses the attachment protein (P1A\[8\]) from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain. |
Inclusion Criteria: Healthy Adults: 1. Healthy adult subjects of either sex, between 18 to 45 years of age; 2. No apparent signs or symptoms of ill health; 3. Subjects properly informed about the study and having signed the informed consent form (ICF). In case of subjects' inability to read or wri...
The Heat Stable Rotavirus Vaccine is an investigational vaccine developed by Merck & Company, Inc. (MRK) for the prevention of rotavirus gastroenteritis. It is designed to remain stable without refrigeration, which could make distribution easier in settings where cold-chain storage is difficult. It is currently in Phase 1 clinical development.
The Heat Stable Rotavirus Vaccine is being developed for rotavirus gastroenteritis, an infectious disease that causes diarrhea and vomiting, primarily in infants and young children. The vaccine is intended for use in adults and infants, with trial participants as young as 6 weeks of age.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of the Heat Stable Rotavirus Vaccine. The company sponsored the Phase 1 clinical trial evaluating the vaccine in adults and infants.
The Heat Stable Rotavirus Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
The Heat Stable Rotavirus Vaccine has been studied in one completed Phase 1 trial, NCT02728869, titled Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants. The trial enrolled 100 participants in Bangladesh, was randomized and placebo-controlled, and included healthy volunteers.
Yes, the Heat Stable Rotavirus Vaccine is also known as the Heat Stable Rotavirus (HSRV) Vaccine. HSRV is simply the abbreviated name used for the same investigational vaccine developed by Merck & Company, Inc. (MRK) for rotavirus gastroenteritis.