HIV InfectionsPhase 1NCT01927835
Evaluating the Safety and Immune Response to Two HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults in the United States and South Africa
A Phase 1 study testing DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine and NYVAC-HIV-PT4 vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine and NYVAC-HIV-PT4 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Access to a participating HIV Vaccine Trials Network (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: participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection
- Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
- Good general health as shown by medical history, physical exam, and screening laboratory tests
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- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
- Assessed by the clinic staff as being at "low risk" for HIV infection
- Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female and greater than or equal to 13.0 g/dL for participants who were born male
- 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 panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal (IULN); creatinine less than or equal to 1.1 times the IULN
- Cardiac Troponin T or I (cTnT or cTnI) does not exceed the IULN
- Negative HIV-1 and -2 blood test: U.S. participants must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. 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
- 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).
- Participants who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination
- Reproductive status: a participant who was born female must agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. More information on this criterion can be found in the protocol.
- Participants who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Who cannot join
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or known hyperlipidemia
- Intent to participate in another study of an investigational research agent during the planned duration of this study
- Pregnant or breastfeeding
- HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 101 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis.
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- Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA or (South Africa) Medicines Control Council (MCC). For participants who have received control/placebo in an experimental vaccine trial, the HVTN 101 PSRT will determine eligibility on a case-by-case basis. For participants who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 101 PSRT on a case-by-case basis.
- Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, hepatitis A or B)
- Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
- Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
- Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
- Immunoglobulin received within 60 days before first vaccination
- Autoimmune disease (Not excluded: mild, well-controlled psoriasis)
- Immunodeficiency
- Untreated or incompletely treated syphilis infection
- Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the protocol.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent
- Psychiatric condition that precludes compliance with the protocol. Specifically excluded are people with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
- Thyroidectomy, or thyroid disease requiring medication during the last 12 months
- Hypertension:
- If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. More information on this criterion can be found in the protocol.
- If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, or clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
- Electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by the contract ECG lab, cardiologist, or study clinician. More information on this criterion can be found in the protocol.
- Participants who have 2 or more of the following cardiac risk factors: (1) participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL; (2) first degree relative (e.g., mother, father, brother, or sister) who had coronary artery disease before the age of 50 years); (3) current smoker; or (4) BMI greater than or equal to 35
- Allergy to eggs or egg products
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
- Malignancy (Not excluded: participant who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure or who is unlikely to experience recurrence of malignancy during the period of the study)
- Seizure disorder: History of seizure(s) within past 3 years. Also exclude if participant has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
- Asplenia: any condition resulting in the absence of a functional spleen
- History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Regimens Comprising DNA-HIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX B/E in Healthy, HIV-Uninfected US and South African Adults
The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.
Read the detailed description
This study will evaluate the safety, tolerability, and immune response to two different vaccine schedules of a prime with either DNA HIV vaccine (DNA-HIV-PT123), or NYVAC HIV vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) followed by a boost combination of NYVAC HIV vaccine (PT1 \& PT4) and AIDSVAX B/E. Study researchers will also evaluate whether body mass index (BMI) and/or sex impact the immunogenicity of the vaccine regimens in participants from South Africa, and look at regional differences in immunologic responses between United States and South African participants.
The study will enroll 264 healthy, HIV-uninfected people, ages 18-50, in the United States and South Africa.
Participants will be randomly assigned to one of three groups and receive either one of the vaccine regimens or placebo. Participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6.
Participants will remain in the clinic for 30 minutes after receiving the vaccines for observation and monitoring. For 7 days after receiving the vaccines, participants will record their symptoms and report them to study researchers.
Study visits will occur at study entry, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. All study visits will include a physical examination, HIV risk reduction counseling, and interviews and/or questionnaires. Select study visits will include urine collection, an electrocardiogram (ECG), blood collection, a pregnancy test for female participants, and HIV testing. At some visits, some participants may also provide samples of cervical fluid, rectal fluid, and/or semen. Study researchers will contact participants by telephone or e-mail once a year for 3 years following the first vaccination for follow-up health monitoring.
- Conditions
- HIV Infections
- Being tested
- DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine, NYVAC-HIV-PT4 vaccine, AIDSVAX B/E vaccine, Placebo for DNA/NYVAC/AIDSVAX
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA-HIV-PT123 vaccineBiological
4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered IM
NYVAC-HIV-PT1 vaccineBiological
≥ 5x10^6 PFU/ml encoding clade C ZM96 gp140 for a planned maximum dose of 1.2x10^8 PFU/ml; administered IM
NYVAC-HIV-PT4 vaccineBiological
≥ 5x10^6 PFU encoding ZM96 Gag and CN54 Pol-Nef, administered IM for a planned maximum dose of 1.1x10^7 PFU/ml; administered IM
AIDSVAX B/E vaccineBiological
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered IM
Placebo for DNA/NYVAC/AIDSVAXBiological
Sodium Chloride for injection, 0.9%; administered IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: Treatment | Experimental | Participants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: DNA-HIV-PT123 vaccine; Biological: NYVAC-HIV-PT1 vaccine; Biological: NYVAC-HIV-PT4 vaccine; Biological: AIDSVAX B/E vaccine; Biological: Placebo for DNA/NYVAC/AIDSVAX |
| Group 1B: Treatment | Experimental | Participants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: DNA-HIV-PT123 vaccine; Biological: NYVAC-HIV-PT1 vaccine; Biological: NYVAC-HIV-PT4 vaccine; Biological: AIDSVAX B/E vaccine; Biological: Placebo for DNA/NYVAC/AIDSVAX |
| Group 2A: Treatment | Experimental | Participants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: NYVAC-HIV-PT1 vaccine; Biological: NYVAC-HIV-PT4 vaccine; Biological: AIDSVAX B/E vaccine |
| Group 2B: Treatment | Experimental | Participants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: NYVAC-HIV-PT1 vaccine; Biological: NYVAC-HIV-PT4 vaccine; Biological: AIDSVAX B/E vaccine |
| Group 3A: Placebo | Placebo comparator | Participants will receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid, and 1 injection of placebo (sodium chloride for injection, 0.9%) administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: Placebo for DNA/NYVAC/AIDSVAX |
| Group 3B: Placebo | Placebo comparator | Participants will receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid, and 1 injection of placebo (sodium chloride for injection, 0.9%) administered as 1 mL IM in the right deltoid at Months 3 and 6. Receives: Biological: Placebo for DNA/NYVAC/AIDSVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of severe local and systemic reactogenicity signs and symptoms
Including pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms
Measured: Measured within the initial 7-day period following each vaccination visit and followed until resolution
Frequency of adverse events (AEs)
Including by treatment arm, by body system, Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products
Measured: Measured through participants' last study visit at Month 12
Reports of serious adverse events (SAEs) throughout the active surveillance period
Measured: Measured through the end of participants' 3-year follow-up period
Measurements of laboratory measures of safety
Including boxplots of white blood cells (WBC), neutrophils, lymphocytes, hemoglobin, platelets, alanine aminotransferase (ALT), and creatinine at baseline and following vaccinations, by treatment arm
Measured: Measured through participants' last study visit at Month 12
Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
HIV-specific CD4+ and CD8+ T-cell response rates
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Magnitude of HIV-specific CD4+ and CD8+ T-cell responses
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Humoral and cellular vaccine responses for each vaccine regimen in South African men with low BMI and with high BMI
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular vaccine responses for each vaccine regimen in South African women with low BMI and with high BMI
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime followed by NYVAC+AIDSVAX B/E in U.S. adults compared to South African adults
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to NYVAC prime followed by NYVAC+AIDSVAX B/E boost in U.S. adults compared to South African adults
Measured: Measured through participants' last study visit at Month 12
Secondary outcomes (9)
Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
HIV-specific CD4+ and CD8+ T-cell response rates
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Magnitude of HIV-specific CD4+ and CD8+ T-cell responses
Measured: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Humoral and cellular vaccine responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African women compared to South African men
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African women
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts in South African men
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular vaccine responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African adults with low and with high BMI
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts in high BMI South African adults
Measured: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in low BMI South African adults
Measured: Measured through participants' last study visit at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, IPPOX Foundation, EuroVacc Foundation, Global Solutions for Infectious Diseases (GSID)
- Responsible party
- Sponsor
- Investigators
- Magdalena Sobieszczyk, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927835
- Sponsor's protocol ID
- HVTN 101
- Other IDs
- 11933
- Status last verified
- Oct 2021
- First submitted
- 20 Aug 2013
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Regimens Comprising DNA-HIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX B/E in Healthy, HIV-Uninfected US and South African Adults
- ClinicalTrials.gov ID
- NCT01927835
- Acronym / sponsor ID
- HVTN 101
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, IPPOX Foundation, EuroVacc Foundation, Global Solutions for Infectious Diseases (GSID)
- Primary completion
- Jan 2017 (estimated)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.
Detailed description
This study will evaluate the safety, tolerability, and immune response to two different vaccine schedules of a prime with either DNA HIV vaccine (DNA-HIV-PT123), or NYVAC HIV vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) followed by a boost combination of NYVAC HIV vaccine (PT1 \& PT4) and AIDSVAX B/E. Study researchers will also evaluate whether body mass index (BMI) and/or sex impact the immunogenicity of the vaccine regimens in participants from South Africa, and look at regional differences in immunologic responses between United States and South African participants.
The study will enroll 264 healthy, HIV-uninfected people, ages 18-50, in the United States and South Africa.
Participants will be randomly assigned to one of three groups and receive either one of the vaccine regimens or placebo. Participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6.
Participants will remain in the clinic for 30 minutes after receiving the vaccines for observation and monitoring. For 7 days after receiving the vaccines, participants will record their symptoms and report them to study researchers.
Study visits will occur at study entry, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. All study visits will include a physical examination, HIV risk reduction counseling, and interviews and/or questionnaires. Select study visits will include urine collection, an electrocardiogram (ECG), blood collection, a pregnancy test for female participants, and HIV testing. At some visits, some participants may also provide samples of cervical fluid, rectal fluid, and/or semen. Study researchers will contact participants by telephone or e-mail once a year for 3 years following the first vaccination for follow-up health monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1A: Treatment | Experimental | Biological: DNA-HIV-PT123 vaccine, Biological: NYVAC-HIV-PT1 vaccine, Biological: NYVAC-HIV-PT4 vaccine, Biological: AIDSVAX B/E vaccine, Biological: Placebo for DNA/NYVAC/AIDSVAXParticipants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. |
| Group 1B: Treatment | Experimental | Biological: DNA-HIV-PT123 vaccine, Biological: NYVAC-HIV-PT1 vaccine, Biological: NYVAC-HIV-PT4 vaccine, Biological: AIDSVAX B/E vaccine, Biological: Placebo for DNA/NYVAC/AIDSVAXParticipants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. |
| Group 2A: Treatment | Experimental | Biological: NYVAC-HIV-PT1 vaccine, Biological: NYVAC-HIV-PT4 vaccine, Biological: AIDSVAX B/E vaccineParticipants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. |
| Group 2B: Treatment | Experimental | Biological: NYVAC-HIV-PT1 vaccine, Biological: NYVAC-HIV-PT4 vaccine, Biological: AIDSVAX B/E vaccineParticipants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6. |
| Group 3A: Placebo | Placebo comparator | Biological: Placebo for DNA/NYVAC/AIDSVAXParticipants will receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid, and 1 injection of placebo (sodium chloride for injection, 0.9%) administered as 1 mL IM in the right deltoid at Months 3 and 6. |
| Group 3B: Placebo | Placebo comparator | Biological: Placebo for DNA/NYVAC/AIDSVAXParticipants will receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive two injections of placebo (sodium chloride for injection, 0.9%) each administered as 1 mL IM in the left deltoid, and 1 injection of placebo (sodium chloride for injection, 0.9%) administered as 1 mL IM in the right deltoid at Months 3 and 6. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Access to a participating HIV Vaccine Trials Network (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: participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection
- Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
Key exclusion criteria (35 listed)
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or known hyperlipidemia
- Intent to participate in another study of an investigational research agent during the planned duration of this study
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA-HIV-PT123 vaccine4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered IM | Biological | Group 1A: Treatment, Group 1B: Treatment |
| NYVAC-HIV-PT1 vaccine≥ 5x10^6 PFU/ml encoding clade C ZM96 gp140 for a planned maximum dose of 1.2x10^8 PFU/ml; administered IM | Biological | Group 1A: Treatment, Group 1B: Treatment, Group 2A: Treatment, Group 2B: Treatment |
| NYVAC-HIV-PT4 vaccine≥ 5x10^6 PFU encoding ZM96 Gag and CN54 Pol-Nef, administered IM for a planned maximum dose of 1.1x10^7 PFU/ml; administered IM | Biological | Group 1A: Treatment, Group 1B: Treatment, Group 2A: Treatment, Group 2B: Treatment |
| AIDSVAX B/E vaccine300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered IM | Biological | Group 1A: Treatment, Group 1B: Treatment, Group 2A: Treatment, Group 2B: Treatment |
| Placebo for DNA/NYVAC/AIDSVAXSodium Chloride for injection, 0.9%; administered IM | Biological | Group 1A: Treatment, Group 1B: Treatment, Group 3A: Placebo, Group 3B: Placebo |
Primary outcome
Frequency of severe local and systemic reactogenicity signs and symptoms
Time frame: Measured within the initial 7-day period following each vaccination visit and followed until resolution
Including pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms
Frequency of adverse events (AEs)
Time frame: Measured through participants' last study visit at Month 12
Including by treatment arm, by body system, Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products
Reports of serious adverse events (SAEs) throughout the active surveillance period
Time frame: Measured through the end of participants' 3-year follow-up period
Measurements of laboratory measures of safety
Time frame: Measured through participants' last study visit at Month 12
Including boxplots of white blood cells (WBC), neutrophils, lymphocytes, hemoglobin, platelets, alanine aminotransferase (ALT), and creatinine at baseline and following vaccinations, by treatment arm
Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
HIV-specific CD4+ and CD8+ T-cell response rates
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Magnitude of HIV-specific CD4+ and CD8+ T-cell responses
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Humoral and cellular vaccine responses for each vaccine regimen in South African men with low BMI and with high BMI
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular vaccine responses for each vaccine regimen in South African women with low BMI and with high BMI
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime followed by NYVAC+AIDSVAX B/E in U.S. adults compared to South African adults
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to NYVAC prime followed by NYVAC+AIDSVAX B/E boost in U.S. adults compared to South African adults
Time frame: Measured through participants' last study visit at Month 12
9 secondary outcomes
Magnitude and breadth of HIV-specific binding antibody responses as assessed by multiplex assay
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
HIV-specific CD4+ and CD8+ T-cell response rates
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Magnitude of HIV-specific CD4+ and CD8+ T-cell responses
Time frame: Measured 2 weeks after the second NYVAC+AIDSVAX B/E boost or final placebo injection
Humoral and cellular vaccine responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African women compared to South African men
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African women
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts in South African men
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular vaccine responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in South African adults with low and with high BMI
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts in high BMI South African adults
Time frame: Measured through participants' last study visit at Month 12
Humoral and cellular responses to DNA prime with NYVAC+AIDSVAX B/E boosts and NYVAC prime with NYVAC+AIDSVAX B/E boosts regimens in low BMI South African adults
Time frame: Measured through participants' last study visit at Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Sobieszczyk study chair
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine and NYVAC-HIV-PT4 vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of severe local and systemic reactogenicity signs and symptoms (time frame: Measured within the initial 7-day period following each vaccination visit and followed until resolution). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.