Clinical trial NCT01177202: Study of the Safety and Immunogenicity of H1N1 Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: H1N1 Flu
Keywords: HAC1, H1N1
Lead sponsor: Fraunhofer, Center for Molecular Biotechnology
Sponsor class: INDUSTRY
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
name: Defense Advanced Research Projects Agency
First posted: 2010-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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
* Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
* History of drug or chemical abuse in the year before the study
* Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
* Unwilling to allow storage of specimens for future use
* Acute disease within 72 hours prior to vaccination: Acute disease is defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever (\>38ºC /\>100.4ºF), or an oral temperature of \>38ºC orally; Study vaccine can be administered to persons with a minor illness.
* Any condition that, in the opinion of the investigator, might interfere with interpretation of data supporting the primary study objectives

Primary outcomes:
measure: To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.
timeFrame: Six Months
Secondary outcomes:
measure: To assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations.
timeFrame: Six Months
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research (WRAIR)
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: James F Cummings, MD, LTC(P), MC, USA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cummings JF, Guerrero ML, Moon JE, Waterman P, Nielsen RK, Jefferson S, Gross FL, Hancock K, Katz JM, Yusibov V; Fraunhofer USA Center for Molecular Biotechnology Study Group. Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: a Phase 1 dose-escalation study in healthy adults. Vaccine. 2014 Apr 17;32(19):2251-9. doi: 10.1016/j.vaccine.2013.10.017. Epub 2013 Oct 12.