A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Orally-administered Replication-competent Adenovirus Type-4 HIV Vaccine Regimens in Combination With an AIDSVAX® B/E Boost in Healthy, HIV-uninfected Adult Participants

Emergent BioSolutions1 site in 1 country20 target enrollmentMarch 2015

ConditionsHealthy Volunteer HIV Vaccine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteer
Sponsor: Emergent BioSolutions
Enrollment: 20
Locations: 1
Primary Endpoint: To evaluate the safety of the Ad4-mgag and Ad4-EnvC150 vaccines in humans when administered via the oral route in combination with an AIDSVAX® B/E boost.
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

February 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Emergent BioSolutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General and Demographic Criteria
•Age of 18 to 49 years.
•Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
•Ability and willingness to provide informed consent
•Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
•Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study vaccination.
•Agrees not to enroll in another study of an investigational research agent during the study period.
•Good general health as shown by medical history, physical exam, and screening laboratory tests without clinically significant findings within the 8 weeks prior to enrollment
•Willing to provide nasal, rectal, and cervical (for people born female) mucosal secretion samples and throat, nasal and rectal swab samples (see Appendix J)
•HIV-Related Criteria:

Exclusion Criteria

•Blood products received within 120 days before first vaccination
•Investigational research agents received within 30 days before first vaccination
•Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
•Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 110 study
•Pregnant, breastfeeding, or planning pregnancy before 28 days following the final vaccination
•Participant whose intimate contacts do not agree to enroll in the study or consent to be tested for VISP.
•Participants who live in the same house or apartment with, have intimate contact with, or care for, any of the following:
•An individual under 18 years or over 65 years of age.
•An individual with known HIV infection
•An immunocompromised or immunosuppressed individual

Outcomes

Primary Outcomes

To evaluate the safety of the Ad4-mgag and Ad4-EnvC150 vaccines in humans when administered via the oral route in combination with an AIDSVAX® B/E boost.

Time Frame: 14 months

To evaluate vaccine tolerability in terms of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and AEs and SAEs.