Overview

A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infe

Status:
Active, not recruiting
Trial end date:
2021-11-30
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Vaccines & Prevention B.V.
Collaborators:
Beth Israel Deaconess Medical Center
Military HIV Research Program
Ragon Institute
Ragon Institute of MGH, MIT and Harvard
US Military HIV Research Program
Criteria
Inclusion Criteria:

- Each participant must have documented Human immunodeficiency virus type1 (HIV-1)
infection

- Each participant must be on suppressive antiretroviral treatment (ART) for at least 48
weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior
to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability
reasons only until 4 weeks prior to screening

- Each participant must have started ART outside of the acute or early phase of
infection

- Each participant must have a plasma HIV ribonucleic acid (RNA) less than (<) 50
copies/ milliliter (mL) at screening and at least one documented evidence of plasma
HIV RNA <50 copies/mL after the last ART change. In case of ART change within the 48
weeks prior randomization, at least one additional more recent documented plasma HIV
RNA <50 copies/mL is required. One blip of HIV RNA greater than (>)50 and <200
copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most
recent (after last ART change, tested before and/or during screening) HIV RNA results
are <50 copies/mL

- Each participant must be medically stable as confirmed by medical history, physical
examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory
tests performed at screening

Exclusion Criteria:

- Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled
in this study, or within 3 months after the last vaccination

- Anyone with contraindication to intramuscular injections and blood draws example,
bleeding disorders

- Anyone with acute illness (this does not include minor illnesses such as diarrhea or
mild upper respiratory tract infection) or temperature greater than or equal to (>=)
38.0ÂșC (degree centigrade) within 24 hours prior to the first dose of study vaccine;
enrollment at a later date is permitted

- Anyone with a history of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
malignancy, which is considered cured with minimal risk of recurrence)

- Anyone with a history of an underlying clinically significant acute or uncontrolled
chronic medical condition or physical examination findings for which, in the opinion
of the investigator, participation would not be in the best interest of the
participant (example, compromise the well-being) or that could prevent, limit, or
confound the protocol-specified assessments

- Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness
according to Centers for Disease Control and prevention (CDC) criteria based on
available medical history and assessed by the investigator as clinically relevant. A
case summary for every participant with AIDS-defining illnesses assessed by the
investigator as clinically irrelevant must be provided to the sponsor and Protocol
Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis
prior to randomization

- Anyone with a history of CD4+ less than (<) 200 cells per millimeter cube
(cells/mm^3), based on available medical history and assessed by the investigator as
clinically relevant. A case summary for every participant with history of CD4+ <200
cells/mm^3 assessed by the investigator as clinically irrelevant must be provided to
the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to
randomization

- Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test)
or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive,
HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV
infection) or syphilis infection that has not been effectively treated. Positive
syphilis serology due to past effectively treated infection is not exclusionary

- Anyone who received or plans to receive: a) licensed live attenuated vaccines within
28 days before or after planned administration of any of the study vaccinations; b)
other licensed (not live) vaccines - within 14 days before or after planned
administration of any of the study vaccinations

- Anyone who received an investigational drug or used an invasive investigational
medical device within 30 days or received an investigational vaccine within 6 months
before the planned administration of the first dose of study vaccine. Receipt of
prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary.
Exceptions: Participants can be included where the vaccine received was subsequently
licensed. Participants with proof of having received only a placebo vaccine can also
be included