Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults



Status:Active, not recruiting
Conditions:Healthy Studies, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 50
Updated:3/23/2019
Start Date:July 8, 2016
End Date:June 30, 2021

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A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; Priming With Trivalent Ad26.Mos.HIV and Boosting With Trivalent Ad26.Mos.HIV And Clade C Gp140 Plus Adjuvant or Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant

The purpose of this study is to assess the safety/tolerability of the 2 different vaccine
regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and
Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with
Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the
different vaccine schedules will be assessed.


Inclusion Criteria:

- Are negative for human immunodeficiency virus (HIV) infection at screening

- Is healthy on the basis of physical examination, medical history, electrocardiogram
(ECG), and vital signs measurement performed at screening

- Are willing/able to adhere to the prohibitions and restrictions specified in the
protocol and study procedures

- Female participants of childbearing potential must have a negative serum pregnancy
test (beta human chorionic gonadotropin [beta hCG]) at the Screening visit, and a
negative urine pregnancy test pre-dose on Day 1

- Are assessed by the clinic staff as being at low risk for HIV infection

Exclusion Criteria:

- Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active
hepatitis C (measured by hepatitis C virus [HCV] Ab test; if positive, HCV ribonucleic
acid [RNA] PCR test will be used to confirm active versus past HCV infection), active
syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented
by serology unless positive serology is due to past treated infection

- Has had a thyroidectomy or active thyroid disease requiring medication during the last
12 months (not excluded: a stable thyroid supplementation)

- Has had major psychiatric illness and/or substance abuse problems during the past 12
months (including hospitalization or periods of work disability) that in the opinion
of the investigator would preclude participation

- Has been in receipt of any licensed vaccine within 14 days prior to the first dose of
study vaccine/placebo, plans to receive within 14 days after the first study
vaccination, or plans to receive within 14 days before or after the second, third or
fourth vaccination

- Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or
a recipient of other experimental vaccine(s) within the last 12 months prior to the
Day 1 visit (Vaccination 1). For participants who received an experimental vaccine
(except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1),
documentation of the identity of the experimental vaccine must be provided to the
sponsor, who will determine eligibility on a case-by-case basis
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