HIV InfectionsPhase 1NCT00991354
Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults
A Phase 1 study testing PENNVAX-B and IL-12 DNA plasmids in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation. 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?
- PENNVAX-B and IL-12 DNA plasmids
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Mar 2011
- 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 HVTN 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 and the Step Study results; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Willing to receive HIV test results
- Willingness to discuss HIV infection risks, amenable to risk reduction counseling, 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 on the basis of behaviors within the 12 months prior to enrollment
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- Good general health as shown by medical history, physical exam, and screening laboratory tests
- Certain laboratory values. Details on this criterion can be found in the protocol.
- Negative HIV-1 and -2 blood test: US participants must have a negative FDA-approved enzyme immunoassay (EIA).
- 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
- Volunteers 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 volunteer who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through the last required protocol clinic visit for sexual activity that could lead to pregnancy, or not be of reproductive potential, or be sexually abstinent
- Volunteers 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
- Within the 12 months prior to enrollment: excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other illicit drug use
- Within the 12 months prior to enrollment: a history of newly acquired or diagnosed syphilis; newly acquired gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, or chancroid
- Untreated or incompletely treated syphilis infection
- HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, documentation of the identity of the study control/placebo must be provided to the HVTN 080 PSRT, who will determine eligibility on a case-by-case basis.
- 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 for those who have received control/placebo in an experimental vaccine trial.
- Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical corticosteroids for mild, uncomplicated dermatitis or [3] oral/parenteral corticosteroids given for non-chronic conditions not expected to recur [length of therapy 10 days or less with completion at least 30 days prior to enrollment])
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- Blood products received within 120 days before first vaccination
- Immunoglobulin received within 60 days before first vaccination
- Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection
- Investigational research agents received within 30 days before first vaccination
- Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 080 study
- 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, HPV)
- Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Allergy to amide-type local anesthetics
- Presence of implanted electronic medical device (e.g., pacemaker, implantable cardioverter defibrillator)
- A history of cardiac arrhythmia, e.g., supraventricular tachycardia, atrial fibrillation, or frequent ectopy on exam. (Not excluded: sinus arrhythmia)
- Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health.
- 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
- Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
- Autoimmune disease
- Immunodeficiency
- Asthma other than mild, well-controlled asthma.
- 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
- Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
- Hypertension
- BMI > 30 kg/m2
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
- Malignancy (Not excluded: a participant with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the period of the study.)
- Seizure disorder
- Asplenia: any condition resulting in the absence of a functional spleen
- Psychiatric condition that precludes compliance with the protocol
- Pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
3535 Market Street CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester HVTN CRS
Rochester, New York, 14642-0001
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX™-B (Gag, Pol, Env) Vaccine, With or Without IL-12 DNA Plasmid, Delivered Via Electroporation in Healthy, HIV-1-Uninfected Adult Participants
An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.
Read the detailed description
An effective and safe vaccine must be developed in order to halt the HIV pandemic. The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation.
Participants in this study will be randomly assigned to one of three groups and will visit the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment. These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3.
At clinic visits participants will have physical exams and blood and urine collected. After receiving study injections, participants will be observed in the clinic for at least 30 minutes. In addition, participants will be asked to monitor symptoms for 3 days after each injection.
- Conditions
- HIV Infections
- Being tested
- PENNVAX-B, IL-12 DNA plasmids
- Keywords
- HIV Seronegativity, HIV Preventive 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.
PENNVAX-BBiological
DNA vaccine encoding the Gag, Pol, and Env proteins of HIV
IL-12 DNA plasmidsBiological
Adjuvant for HIV vaccines
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive 3 mg of PENNVAX-B vaccine or placebo at Months 0, 1, and 3. Receives: Biological: PENNVAX-B |
| Group 2 | Experimental | Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3. Receives: Biological: PENNVAX-B; Biological: IL-12 DNA plasmids |
| Group 3 | Experimental | Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3. Receives: Biological: PENNVAX-B; Biological: IL-12 DNA plasmids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of local injection/EP site reactogenicity signs and symptoms
Measured: Throughout study
Magnitude of local injection/EP site pain as measured by a VAS
Measured: Throughout study
Frequency of AEs categorized by MedDRA body system, MedDRA preferred term, severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting
Measured: Throughout study
WBC, neutrophils, lymphocytes, hemoglobin, alkaline phosphatase, platelets, ALT, AST, creatinine, and creatine phosphokinase (CPK)
Measured: At baseline and post-vaccinations
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Measured: Throughout study
Distribution of responses to questions regarding acceptability of study injections via EP
Measured: Throughout study
Secondary outcomes (5)
Frequency of T-cell responses as measured by IFN-γ ELISpot
Measured: Two Weeks after the second and third vaccinations
Frequency of CD4+ T cell responses measured by intracellular cytokine staining (ICS) for IFN-γ and/or IL-2 to HIV potential T-cell epitope (PTE) peptide pools representing Gag, Pol, and Env
Measured: After the second and third vaccinations
Frequency of CD8+ T cell responses measured by ICS for IFN-γ and/or IL-2 to HIV PTE peptide pools representing Gag, Pol, and Env
Measured: After the second and third vaccinations
Frequency of humoral responses detected by HIV-1-specific neutralizing and binding antibody assays from serum samples
Measured: Two weeks after last vaccination
Frequency of vaccine-induced positive results with end-of-study HIV serological testing by commercial assays
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991354
- Sponsor's protocol ID
- HVTN 080
- Other IDs
- 10741
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2009
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
PubMed 25820067
Study at a glance
From the registry record, last updated by the sponsor on 14 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 PENNVAX™-B (Gag, Pol, Env) Vaccine, With or Without IL-12 DNA Plasmid, Delivered Via Electroporation in Healthy, HIV-1-Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00991354
- Acronym / sponsor ID
- HVTN 080
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Oct 2009 (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.
An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.
Detailed description
An effective and safe vaccine must be developed in order to halt the HIV pandemic. The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation.
Participants in this study will be randomly assigned to one of three groups and will visit the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment. These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3.
At clinic visits participants will have physical exams and blood and urine collected. After receiving study injections, participants will be observed in the clinic for at least 30 minutes. In addition, participants will be asked to monitor symptoms for 3 days after each injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: PENNVAX-BParticipants will receive 3 mg of PENNVAX-B vaccine or placebo at Months 0, 1, and 3. |
| Group 2 | Experimental | Biological: PENNVAX-B, Biological: IL-12 DNA plasmidsParticipants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3. |
| Group 3 | Experimental | Biological: PENNVAX-B, Biological: IL-12 DNA plasmidsParticipants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Access to a participating HVTN 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 and the Step Study results; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Willing to receive HIV test results
- Willingness to discuss HIV infection risks, amenable to risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
Key exclusion criteria (34 listed)
- Within the 12 months prior to enrollment: excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other illicit drug use
- Within the 12 months prior to enrollment: a history of newly acquired or diagnosed syphilis; newly acquired gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, or chancroid
- Untreated or incompletely treated syphilis infection
- HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, documentation of the identity of the study control/placebo must be provided to the HVTN 080 PSRT, who will determine eligibility on a case-by-case basis.
- 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 for those who have received control/placebo in an experimental vaccine trial.
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 |
|---|---|---|
| PENNVAX-BDNA vaccine encoding the Gag, Pol, and Env proteins of HIV | Biological | Group 1, Group 2, Group 3 |
| IL-12 DNA plasmidsAdjuvant for HIV vaccines | Biological | Group 2, Group 3 |
Primary outcome
Frequency and severity of local injection/EP site reactogenicity signs and symptoms
Time frame: Throughout study
Magnitude of local injection/EP site pain as measured by a VAS
Time frame: Throughout study
Frequency of AEs categorized by MedDRA body system, MedDRA preferred term, severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting
Time frame: Throughout study
WBC, neutrophils, lymphocytes, hemoglobin, alkaline phosphatase, platelets, ALT, AST, creatinine, and creatine phosphokinase (CPK)
Time frame: At baseline and post-vaccinations
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Time frame: Throughout study
Distribution of responses to questions regarding acceptability of study injections via EP
Time frame: Throughout study
5 secondary outcomes
Frequency of T-cell responses as measured by IFN-γ ELISpot
Time frame: Two Weeks after the second and third vaccinations
Frequency of CD4+ T cell responses measured by intracellular cytokine staining (ICS) for IFN-γ and/or IL-2 to HIV potential T-cell epitope (PTE) peptide pools representing Gag, Pol, and Env
Time frame: After the second and third vaccinations
Frequency of CD8+ T cell responses measured by ICS for IFN-γ and/or IL-2 to HIV PTE peptide pools representing Gag, Pol, and Env
Time frame: After the second and third vaccinations
Frequency of humoral responses detected by HIV-1-specific neutralizing and binding antibody assays from serum samples
Time frame: Two weeks after last vaccination
Frequency of vaccine-induced positive results with end-of-study HIV serological testing by commercial assays
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 25820067Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PENNVAX-B and IL-12 DNA plasmids in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
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 14 inclusion and 34 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and severity of local injection/EP site reactogenicity signs and symptoms (time frame: Throughout study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991354, which also lists 1 linked publication.
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 14 Oct 2021.