CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults
NCT Number: NCT06485258
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Rotavirus Infections
Interventions: BIOLOGICAL: 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)|BIOLOGICAL: 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)|OTHER: Placebo
Sponsor: Centers for Disease Control and Prevention
Collaborators: Emory-Children's Center|Bill and Melinda Gates Foundation|Children's Hospital Medical Center, Cincinnati
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2025-10-14
Locations: Emory Children's Center - Vaccine Research Clinic, Atlanta, Georgia, 30322, United States

Summary:
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.

Primary Outcome Measures: Any unsolicited adverse events, The number of vaccine-related unsolicited adverse events following each vaccination. Unsolicited AEs will be collected continuously from vaccination on Day 1 through 28 days after the last vaccination (Day 85), Up to Day 29 following each vaccination or placebo|Any serious adverse events, The number vaccine-related serious adverse events from vaccination until end of the study. SAEs will be collected from Day 1 (after study product administration) through the last study visit (Day 237), Up to end of the study (Day 237)|Any solicited site reactions from vaccination, The subject will be provided with a memory aid, thermometer and ruler and will be instructed to record the presence of solicited local injection site symptoms and oral temperature through the 7 days after each vaccine, Up to Day 8 following vaccination or placebo|Any solicited systemic reactions from vaccination, The subject will be provided with a memory aid, thermometer and ruler and will be instructed to record the presence of solicited systemic symptoms and oral temperature through the 7 days after each vaccine, Up to Day 8 following vaccination or placebo|Any new-onset medical conditions (NOMC), The number of new-onset medical conditions (NOMC) from first vaccination until end of the study, Day 1 vaccination or placebo through end of the study (Day 237)|Any medically attended adverse events (MAAEs) from first vaccination until end of the study, The number of medically attended adverse events (MAAES), From Day 1 vaccination or placebo through the end of the study (Day 237)
Secondary Outcome Measures: Percentage of Subjects with Rotavirus IgG or Neutralizing Antibody Seroconversion, Seroconversion defined as a four-fold increase in antibody titers between baseline to 4 weeks post 3rd vaccination, Baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)|Geometric Mean Titer (GMT) of rotavirus Immunoglobulin G (IgG) and Neutralizing Antibody Titer, Measured from sera to be collected from both cohorts on Day 85, 4 weeks post 3rd vaccination (Day 85)|Geometric Mean Fold Rise (GMFR) of rotavirus Immunoglobulin G (IgG) and Neutralizing Antibody Titer, Measures from sera to be collected from both cohorts on Day 85, 4 weeks post 3rd vaccination (Day 85)
Other Outcome Measures: Percentage of Subjects with Rotavirus Immunoglobulin A (IgA) Seroresponses, Seroconversion defined as four-fold change in antibody titers between baseline to 4 weeks post 3rd vaccination, Baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)|Geometric mean titer (GMT) of Rotavirus Immunoglobulin A (IgA), Measured from sera to be collected from both cohorts on Day 85, 4 weeks post 3rd vaccination (Day 85)|Geometric mean fold rise (GMFR) in rotavirus IgA antibody, Measured from sera to be collected from both cohorts from baseline (Day 0) to Day 85, From baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)|Percentage of Subjects with Rotavirus Immunoglobulin A (IgA), Immunoglobulin G (IgG) or Neutralizing Antibody Seroconversion, Measured from sera collected on Days 0, 8, 29, 36, 57, 65, and 237 (before the first vaccination and 4 weeks after each vaccination), Days 0, 8, 29, 36, 57, 65, and 237|Geometric mean titer (GMT) of Rotavirus Immunoglobulin A (IgA), Immunoglobulin G (IgG) or Neutralizing Antibody, Measured from sera collected from both groups during scheduled clinic visits on Days 0, 8, 29, 36, 57, 65, and 237, Days 0, 8, 29, 36, 57, 65, and 237|Geometric Mean Fold Rise (GMFR) for Rotavirus Immunoglobulin A (IgA), Immunoglobulin G (IgG) or Neutralizing Antibody, Measured from sera collected from both groups during scheduled clinic visits on Days 0, 8, 29, 36, 57, 65, and 237, Days 0, 8, 29, 36, 57, 65, and 237