Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 27 March 2023
• Main ID: NCT03122223
• Date of registration: 14/02/2017
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants HVTN 120
• Scientific title: A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted Clade C Env Protein, in Healthy, HIV-uninfected Adult Participants
• Date of first enrolment: January 16, 2018
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03122223
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

South Africa, Tanzania, United States, Zambia, Zimbabwe

Contacts

• Name: Z Mike Chirenje
• Affiliation: UZ-UCSF Collaborative Research Program

Key inclusion & exclusion criteria

Inclusion Criteria:

General and Demographic Criteria:

- Age of 18 to 40 years

- Access to a participating HVTN clinical research site (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;
provides answers to a questionnaire prior to first vaccination with verbal
demonstration of understanding of all questionnaire items answered incorrectly

- Agrees not to enroll in another study of an investigational research agent before the
last required clinic visit

- Good general health as shown by medical history, physical exam, and screening
laboratory tests

HIV-Related Criteria:

- Willingness to receive HIV test results

- Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling

- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to
maintaining behavior consistent with low risk of HIV exposure through the last
required protocol clinic visit (see the study protocol for more information about low
risk guidelines).

Laboratory Inclusion Values:

Hemogram/Complete Blood Count (CBC):

- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female
sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male
sex at birth. For transgender participants who have been on hormone therapy for more
than 6 consecutive months, determine hemoglobin eligibility based on the gender with
which they identify (ie, a transgender female who has been on hormone therapy for more
than 6 consecutive months should be assessed for eligibility using the hemoglobin
parameters for persons assigned female sex at birth).

- White blood cell count equal to 3,300 to 12,000 cells/mm^3

- Total lymphocyte count greater than or equal to 800 cells/mm^3

- Remaining differential either within institutional normal range or with site physician
approval

- Platelets equal to 125,000 to 550,000/mm^3

Chemistry:

- Chemistry panel: ALT, AST, and ALP less than 1.25 times the institutional upper limit
of normal; creatinine less than or equal to institutional upper limit of normal.

Virology:

- Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved
enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been
approved by HVTN Laboratory Operations.

- Negative Hepatitis B surface antigen (HBsAg)

- Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive

Urine:

- Normal urine:

- Negative urine glucose, and

- Negative or trace urine protein, and

- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
microscopic urinalysis with red blood cells levels within institutional normal
range).

Reproductive Status:

- Volunteers who were assigned female sex at birth: negative serum or urine beta human
chorionic gonadotropin pregnancy test performed prior to vaccination on the day of
initial vaccination. Persons who are NOT of reproductive potential due to having
undergone total hysterectomy or bilateral oophorectomy (verified by medical records),
are not required to undergo pregnancy testing.

- Reproductive status: Africa - A volunteer who was assigned female sex at birth must:

- Agree to consistently use effective contraception (see the study protocol for
more information) for sexual activity that could lead to pregnancy from at least
21 days prior to enrollment through the last required protocol clinic visit.
Effective contraception for participants in Africa is defined as using 2 methods
of birth control. These include 1 of the following methods:

- Condoms (male or female), or

- Diaphragm or cervical cap, PLUS 1 of the following methods:

- Intrauterine device (IUD),

- Hormonal contraception (in accordance with applicable national contraception
guidelines),

- Successful vasectomy in any partner assigned male at birth (considered
successful if a volunteer reports that a male partner has [1] documentation
of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with
no resultant pregnancy despite sexual activity after vasectomy); or

- Any other contraceptive method approved by the HVTN 120 Protocol Safety
Review Team (PSRT)

- Or not be of reproductive potential, such as having reached menopause (no menses
for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal
ligation;

- Or be sexually abstinent.

- Reproductive status: United States - A volunteer who was assigned female sex at birth
must:

- Agree to consistently use effective contraception (see the study protocol for
more information) for sexual activity that could lead to pregnancy from at least
21 days prior to enrollment through the last required protocol clinic visit.
Effective contraception for participants in the United States is defined as using
any 1 or more of the following methods of birth control:

- Condoms (male or female) with or without spermicide,

- Diaphragm or cervical cap with spermicide,

- Intrauterine device (IUD),

- Hormonal contraception, or

- Successful vasectomy in any partner assigned male at birth (considered
successful if a volunteer reports that a male partner has [1] documentation
of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with
no resultant pregnancy despite sexual activity after vasectomy); or

- Any other contraceptive method approved by the HVTN 120 PSRT

- Or must not be of reproductive potential, such as having reached menopause (no
menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or
tubal ligation;

- Or must be sexually abstinent.

- Volunteers who were assigned female sex at birth must also agree not to seek pregnancy



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: Bivalent subtype C gp120/MF59

Biological: ALVAC-HIV (vCP2438)

Biological: Bivalent subtype C gp120/AS01(B)

Biological: Placebo

Primary Outcome(s)

Frequency of Adverse Events by Relationship to the Study Product [Time Frame: Measured through 30 days after each vaccination at Month 0, 1, 3 and 6.]

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen [Time Frame: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6]

Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] [Time Frame: Measured at Month 12]

Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. [Time Frame: Measured at Month 6.5]

Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] [Time Frame: Measured at Month 12]

WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm [Time Frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)]

Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen [Time Frame: Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6]

Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. [Time Frame: Measured at Month 6.5]

Hemoglobin, Creatinine in g/dL [Time Frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)]

Frequency of SAEs, AESIs, and New Chronic Conditions [Time Frame: Measured through Month 18.]

AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. [Time Frame: Measured through month 12]

Alkaline Phosphatase, AST, ALT in U/L [Time Frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)]

Secondary Outcome(s)

Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] [Time Frame: Measured at Month 6.5]

Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] [Time Frame: Measured at Month 6.5]

Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] [Time Frame: Measured at Month 6.5]

Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] [Time Frame: Measured at Month 12]

Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] [Time Frame: Measured at Month 6.5]

Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] [Time Frame: Measured at Month 6.5]

Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] [Time Frame: Measured at Month Month 12]

Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. [Time Frame: Measured at Month 12]

Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. [Time Frame: Measured at Month 12]

Secondary ID(s)

36128

HVTN 120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Sanofi Pasteur, a Sanofi Company

Results

• Results available: Yes
• Date Posted: 08/01/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03122223