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

Fraunhofer, Center for Molecular Biotechnology1 site in 1 country80 target enrollmentSeptember 2010

ConditionsH1N1 Flu

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: H1N1 Flu
Sponsor: Fraunhofer, Center for Molecular Biotechnology
Enrollment: 80
Locations: 1
Primary Endpoint: To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Fraunhofer, Center for Molecular Biotechnology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 - 50 years inclusive
•Able to give written informed consent to participate
•Score of at least 80% correct on a 10 question multiple-choice quiz (2 attempts)
•Healthy, as determined by medical history, physical examination, weight, vital signs, and clinical safety laboratory examinations at baseline
•Females must fulfill one of the following criteria: At least one year post-menopausal; Surgically sterile or have a surgically sterile partner; Willing to abstain from sexual intercourse; Willing to use a reliable form of contraception approved by the investigator (e.g., oral, implantable, transdermal or injectable contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, or male condoms) for 30 days prior to first vaccination through 3 months after second vaccination
•Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
•Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period

Exclusion Criteria

•Prior receipt of 2010-2011 seasonal influenza vaccine containing A/California/04/09-like virus
•Screening H1N1 titer of \> 1:40
•Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
•Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
•Cancer, or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma or squamous cell carcinoma
•Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system: This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable); Inhaled and topical corticosteroids will be allowed
•Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
•Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
•Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination; Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) vaccine up to 8 days before or at least 8 days after a dose of study vaccine will be allowed
•History of anaphylactic type reaction to injected vaccines

Outcomes

Primary Outcomes

To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.

Time Frame: Six Months

The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age.