HIV InfectionsPhase 1NCT01964937
Evaluating the Safety and Immune Response to Five Different Combinations of HIV Vaccines in Healthy, HIV-Uninfected Adults
A Phase 1 study testing DNA-HIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults. 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, NYVAC-HIV-PT1 and NYVAC-HIV-PT4
- 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 Apr 2014
- 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, greater than or equal to 13.0 g/dL for volunteers 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) less than 1.25 times the institutional upper limit of normal (IULN) and creatinine less than or equal to IULN.
- Negative HIV-1 and -2 blood test: U.S. participants must have a negative 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 (anti-HCV) antibodies (Abs), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
- Normal urine: negative urine glucose, 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
- 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); 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.
- 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 years, 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 before the last required protocol clinic visit
- 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 102 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. For participants who have received control/placebo in an experimental vaccine trial, the HVTN 102 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 102 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 persons 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 or moderate, 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. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these participants, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment. 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, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
- 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 three 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 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Different Combinations of DNAHIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX® B/E in Healthy, HIV Uninfected Adult Participants
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.
Read the detailed description
This study will evaluate the safety, tolerability, and immune response to five different combinations of three HIV vaccines-a DNA vaccine (DNA-HIV-PT123), a NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4 injections), and the AIDSVAX® B/E vaccine-in healthy, HIV-uninfected adult participants.
The study will enroll 180 healthy, HIV-uninfected participants aged 18 to 50 years. The participants will be randomly assigned to one of five groups. All participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6. The immune response of different prime and boost vaccine strategies will be tested in Groups 1 through 4, and the immune response of the co-administration of the DNA and AIDSVAX® B/E vaccine will be tested in Group 5. Group 1 participants will receive AIDSVAX® B/E as a prime followed by NYVAC as a boost; Group 2 participants will receive NYVAC as a prime followed by an AIDSVAX® B/E boost; Group 3 participants will receive AIDSVAX® B/E as a prime followed by a DNA boost; Group 4 participants will receive a DNA prime followed by an AIDSVAX® B/E boost; and Group 5 participants will receive both the DNA and AIDSVAX® B/E vaccines at each of the 4 vaccination visits.
Total study duration will be approximately 42 months and will involve 12 months of scheduled clinic visits at screening, study entry [Month 0], and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12) followed by annual health contacts via e-mail or phone to a total of 3 years following initial study injection.
All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine collection, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants in Groups 1 and 2, select study visits will also include an assessment of cardiac symptoms. 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.
- Conditions
- HIV Infections
- Being tested
- DNA-HIV-PT123, NYVAC-HIV-PT1, NYVAC-HIV-PT4, AIDSVAX B/E®, Placebo vaccine
- 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-PT123Biological
The DNA-HIV-PT123 (containing clade C ZM96 gag and gp140 along with CN54 pol-nef) will be administered at a dose of 4 mg IM.
NYVAC-HIV-PT1Biological
The NYVAC-HIV-PT1 vaccine (containing clade C ZM96 gp140) will be administered at a dose of greater than or equal to 5×10^6 plaque-forming units (PFU)IM, for a planned maximum dose of 1.2×10^8 PFU.
NYVAC-HIV-PT4Biological
The NYVAC-HIV-PT4 vaccine (containing ZM96 gag-CN54 pol-nef) will be administered at a dose of greater than or equal to 5×10^6 PFU IM, for a planned maximum dose of 1.1×10^7 PFU.
AIDSVAX B/E®Biological
The AIDSVAX B/E ® vaccine will be administered as a 1 mL/600 mcg dose IM.
Placebo vaccineBiological
The placebo vaccine contains sodium chloride for injection USP, 0.9% and will be administered as a 1 mL injection IM.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | At Months 0 and 1, participants in Group 1 will receive one injection of AIDSVAX B/E ® administered intramuscularly (IM) in the right deltoid and two injections of placebo vaccine administered IM in the left deltoid.
At Months 3 and 6, participants will receive two injections of NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. Receives: Biological: NYVAC-HIV-PT1; Biological: NYVAC-HIV-PT4; Biological: AIDSVAX B/E® |
| Group 2 | Experimental | At Months 0 and 1, participants in Group 2 will receive two injections of NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid.
At Months 3 and 6, participants will receive the AIDSVAX ® B/E vaccine administered IM in the right deltoid and two injections of placebo vaccine administered IM in the left deltoid. Receives: Biological: NYVAC-HIV-PT1; Biological: NYVAC-HIV-PT4; Biological: AIDSVAX B/E® |
| Group 3 | Experimental | At Months 0 and 1, participants in Group 3 will one injection of the AIDSVAX B/E vaccine administered IM in the right deltoid and one injection of placebo vaccine administered IM the left deltoid.
At Months 3 and 6, participants will receive one injection of the DNA-HIV-PT123 vaccine administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. Receives: Biological: DNA-HIV-PT123; Biological: AIDSVAX B/E®; Biological: Placebo vaccine |
| Group 4 | Experimental | At Months 0 and 1, participants in Group 4 will receive one injection of the DNA-HIV-PT123 vaccine administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid.
At Months 3 and 6, participants will receive one injection of the AIDSVAX B/E ® vaccine administered IM in the right deltoid and one injection of placebo vaccine administered IM the left deltoid. Receives: Biological: DNA-HIV-PT123; Biological: AIDSVAX B/E®; Biological: Placebo vaccine |
| Group 5 | Experimental | At Months 0, 1, 3, and 6, participants in Group 5 will receive one injection of the DNA-HIV-PT123 vaccine administered in the left deltoid and one injection of the AIDSVAX B/E ® vaccine administered IM in the right deltoid. Receives: Biological: DNA-HIV-PT123; Biological: AIDSVAX B/E® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity signs and symptoms
Measured: Measured up to 7 days post the last vaccination
Laboratory measures of safety
Measured: Measured through participants' last study visit at Month 12
Adverse events (AEs) and serious adverse events (SAEs)
Measured: Measured through last annual health contact at Month 36
HIV-specific binding antibody (Ab) response as assessed by binding Ab multiplex assay
Measured: Measured 2 weeks after the 4th vaccination (Month 6)
Response rate and magnitude of CD4 and CD8 T-cell responses as assessed by intracellular cytokine staining (ICS) assays
Measured: Measured 2 weeks after the 4th vaccination (Month 6)
Secondary outcomes (3)
HIV-specific binding Ab and T-cell responses
Measured: Measured 2 weeks after the 4th vaccination (Month 6)
Neutralizing antibody (nAb) magnitude and breadth against tier 1 and tier 2 HIV-1 isolates as assessed by area under the magnitude-breadth curves
Measured: Measured 2 weeks after the 4th vaccination (Month 6)
HIV-specific Ab and T-cell responses
Measured: Measured 6 months after the 4th vaccination (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Primary completionApr 2014
- Study completionApr 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- IPPOX Foundation, EuroVacc Foundation, Global Solutions for Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Michael Keefer, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964937
- Sponsor's protocol ID
- HVTN 102
- Other IDs
- 11937
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 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 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Different Combinations of DNAHIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX® B/E in Healthy, HIV Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT01964937
- Acronym / sponsor ID
- HVTN 102
- 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
- IPPOX Foundation, EuroVacc Foundation, Global Solutions for Infectious Diseases
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Oct 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.
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and immune response to five different combinations of three HIV vaccines-a DNA vaccine (DNA-HIV-PT123), a NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4 injections), and the AIDSVAX® B/E vaccine-in healthy, HIV-uninfected adult participants.
The study will enroll 180 healthy, HIV-uninfected participants aged 18 to 50 years. The participants will be randomly assigned to one of five groups. All participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6. The immune response of different prime and boost vaccine strategies will be tested in Groups 1 through 4, and the immune response of the co-administration of the DNA and AIDSVAX® B/E vaccine will be tested in Group 5. Group 1 participants will receive AIDSVAX® B/E as a prime followed by NYVAC as a boost; Group 2 participants will receive NYVAC as a prime followed by an AIDSVAX® B/E boost; Group 3 participants will receive AIDSVAX® B/E as a prime followed by a DNA boost; Group 4 participants will receive a DNA prime followed by an AIDSVAX® B/E boost; and Group 5 participants will receive both the DNA and AIDSVAX® B/E vaccines at each of the 4 vaccination visits.
Total study duration will be approximately 42 months and will involve 12 months of scheduled clinic visits at screening, study entry [Month 0], and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12) followed by annual health contacts via e-mail or phone to a total of 3 years following initial study injection.
All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine collection, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants in Groups 1 and 2, select study visits will also include an assessment of cardiac symptoms. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: NYVAC-HIV-PT1, Biological: NYVAC-HIV-PT4, Biological: AIDSVAX B/E®At Months 0 and 1, participants in Group 1 will receive one injection of AIDSVAX B/E ® administered intramuscularly (IM) in the right deltoid and two injections of placebo vaccine administered IM in the left deltoid. At Months 3 and 6, participants will receive two injections of NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. |
| Group 2 | Experimental | Biological: NYVAC-HIV-PT1, Biological: NYVAC-HIV-PT4, Biological: AIDSVAX B/E®At Months 0 and 1, participants in Group 2 will receive two injections of NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4) administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. At Months 3 and 6, participants will receive the AIDSVAX ® B/E vaccine administered IM in the right deltoid and two injections of placebo vaccine administered IM in the left deltoid. |
| Group 3 | Experimental | Biological: DNA-HIV-PT123, Biological: AIDSVAX B/E®, Biological: Placebo vaccineAt Months 0 and 1, participants in Group 3 will one injection of the AIDSVAX B/E vaccine administered IM in the right deltoid and one injection of placebo vaccine administered IM the left deltoid. At Months 3 and 6, participants will receive one injection of the DNA-HIV-PT123 vaccine administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. |
| Group 4 | Experimental | Biological: DNA-HIV-PT123, Biological: AIDSVAX B/E®, Biological: Placebo vaccineAt Months 0 and 1, participants in Group 4 will receive one injection of the DNA-HIV-PT123 vaccine administered IM in the left deltoid and one injection of placebo vaccine administered IM in the right deltoid. At Months 3 and 6, participants will receive one injection of the AIDSVAX B/E ® vaccine administered IM in the right deltoid and one injection of placebo vaccine administered IM the left deltoid. |
| Group 5 | Experimental | Biological: DNA-HIV-PT123, Biological: AIDSVAX B/E®At Months 0, 1, 3, and 6, participants in Group 5 will receive one injection of the DNA-HIV-PT123 vaccine administered in the left deltoid and one injection of the AIDSVAX B/E ® vaccine administered IM in the right deltoid. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 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 (33 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 years, 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 before the last required protocol clinic visit
- 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-PT123The DNA-HIV-PT123 (containing clade C ZM96 gag and gp140 along with CN54 pol-nef) will be administered at a dose of 4 mg IM. | Biological | Group 3, Group 4, Group 5 |
| NYVAC-HIV-PT1The NYVAC-HIV-PT1 vaccine (containing clade C ZM96 gp140) will be administered at a dose of greater than or equal to 5×10^6 plaque-forming units (PFU)IM, for a planned maximum dose of 1.2×10^8 PFU. | Biological | Group 1, Group 2 |
| NYVAC-HIV-PT4The NYVAC-HIV-PT4 vaccine (containing ZM96 gag-CN54 pol-nef) will be administered at a dose of greater than or equal to 5×10^6 PFU IM, for a planned maximum dose of 1.1×10^7 PFU. | Biological | Group 1, Group 2 |
| AIDSVAX B/E®The AIDSVAX B/E ® vaccine will be administered as a 1 mL/600 mcg dose IM. | Biological | Group 1, Group 2, Group 3, Group 4, Group 5 |
| Placebo vaccineThe placebo vaccine contains sodium chloride for injection USP, 0.9% and will be administered as a 1 mL injection IM. | Biological | Group 3, Group 4 |
Primary outcome
Local and systemic reactogenicity signs and symptoms
Time frame: Measured up to 7 days post the last vaccination
Laboratory measures of safety
Time frame: Measured through participants' last study visit at Month 12
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Measured through last annual health contact at Month 36
HIV-specific binding antibody (Ab) response as assessed by binding Ab multiplex assay
Time frame: Measured 2 weeks after the 4th vaccination (Month 6)
Response rate and magnitude of CD4 and CD8 T-cell responses as assessed by intracellular cytokine staining (ICS) assays
Time frame: Measured 2 weeks after the 4th vaccination (Month 6)
3 secondary outcomes
HIV-specific binding Ab and T-cell responses
Time frame: Measured 2 weeks after the 4th vaccination (Month 6)
Neutralizing antibody (nAb) magnitude and breadth against tier 1 and tier 2 HIV-1 isolates as assessed by area under the magnitude-breadth curves
Time frame: Measured 2 weeks after the 4th vaccination (Month 6)
HIV-specific Ab and T-cell responses
Time frame: Measured 6 months after the 4th vaccination (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.
Michael Keefer study chair
University of Rochester
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA-HIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4 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 22 inclusion and 33 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. 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?
Local and systemic reactogenicity signs and symptoms (time frame: Measured up to 7 days post the last vaccination). The study lists 5 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.