NCT01177202

Study of the Safety and Immunogenicity of H1N1 Vaccine

A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fraunhofer, Center for Molecular Biotechnology · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults

Detailed description

This is a single center, placebo-controlled, single blinded dose escalation study to preliminarily assess the safety, reactogenicity, and immunogenicity of different HAC1 vaccine formulations. This study will assess a novel HAC1 vaccine, which is plant derived. This vaccine will be compared to Placebo of normal (0.9%) saline, and reference vaccine consisting of an approved monovalent vaccine containing an A/California (H1N1)-like strain. Subjects will receive 2 intramuscular injections of the experimental vaccine, placebo, or reference vaccine on Study Days 0 and 21

Conditions

• H1N1 Flu

Interventions

Type	Name	Description
BIOLOGICAL	HAC1 Vaccine	Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-05-01
• Completion: 2012-10-01
• First posted: 2010-08-06
• Last updated: 2016-07-26

Locations

1 site across 1 country: United States