A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults

This is a Phase I, placebo-controlled (the use of an inactive substance identical in
appearance to the active vaccine), double-blind (neither the participant or study personnel
will know the identity of the treatment administered) study where participants will be
randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA)
Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood
of observer and selection bias, provide control for confounding variables, and aid an
unbiased analysis of the study results. The study will include 4 groups of participants, 2
groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd]
vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants
will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The
trial comprises a 4-week screening period, a 12-week vaccination period during which
participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week
follow-up period to the final visit at Week 52.

Inclusion Criteria:

- Healthy adults (determined by medical history, physical examination, and clinical
judgment)

- HIV uninfected

- Female participants of child bearing potential must have a negative serum β-human
chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to
each vaccine/placebo administration, practice adequate birth control measures from 28
days prior to the first vaccine/placebo administration through to at least 3 months
after the final vaccine/placebo administration

- Male participants who are sexually active with a woman of childbearing potential and
has not had a vasectomy must agree to use a double barrier method of birth control,
e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with
occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository

Exclusion Criteria:

- Confirmed HIV-1/-2 infection

- Chronic active hepatitis B or hepatitis C or active syphilis infection. Active
syphilis documented by exam or serology unless positive serology is due to past
treated infection

- Within the 12 months prior to enrollment: a history of newly acquired syphilis,
gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia,
pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis,
proctitis, lymphogranulomavenereum, chancroid, or hepatitis B

- A woman who is breastfeeding

- Any clinically significant acute or chronic medical condition that, in the opinion of
the investigator, would preclude participation

- Major surgery within the 4 weeks prior to study entry or planned major surgery through
the course of the study