Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Vaccines & Prevention B.V.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
