HIV InfectionsPhase 1NCT01260727
Evaluating the Safety of and Immune Response to an HIV Vaccine Followed by Booster, Administered by Two Devices, in HIV-Uninfected Adults
A Phase 1 study testing PENNVAX-G DNA Vaccine and MVA-CMDR Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PENNVAX-G DNA Vaccine and MVA-CMDR Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2010to Jun 2015
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low risk of HIV infection (as defined by the Study Risk Assessment Tool captured during the medical history)
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and committed to 18 months of follow-up contact
- Pass the Test of Understanding and demonstrate an understanding of STEP study results (HVTN 502/Merck 023 trial)
- Assessed by the clinic staff as being at low risk of HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment as follows: sexually abstinent, or had two or fewer mutually monogamous relationships with HIV-uninfected partners and who have not used illicit drugs, or had two or fewer partners believed to be HIV uninfected and who did not use illicit drugs and with whom he/she regularly uses condoms for sexual intercourse
- Healthy men and women (determined by medical history, physical examination, and clinical judgment)
- Available and willing to participate for 12 months for study visits and annual follow-up for 18 months after study completion
Show all 19Show fewer
- Must be willing to have photo or fingerprint taken for identification purposes
- Must be willing to be taken home at enrollment visit and allow home visits, if needed
- Able to read and willing to complete the informed consent process
- Has the following laboratory criteria within 45 days prior to study entry:
- Hemoglobin: Women: 11 mg/dL; Men: 12.5 mg/dL
- White cell count: 2,500 to 11,000 cells/mm^3
- Platelets: 125,000 to 450,000 per mm^3
- Urinalysis: protein and blood less than 1+, glucose negative
- Normal liver function tests to include alanine aminotransferase (ALT)/aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transpeptidase (GGT) (less than or equal to 1.25 times the institutional upper limits of normal), creatine phosphokinase (CPK) (less than or equal to 600 IU/L), troponin I (less than 0.4 ng/mL), and creatinine (less than or equal to 1.25 times the institutional upper limits of normal)
- Negative for HIV infection (enzyme linked immunosorbent assay [ELISA], Western blot [WB], and HIV polymerase chain reaction [PCR])
- Female participants must have a negative pregnancy test at the screening visit and have a negative pregnancy test immediately prior to each vaccine/placebo vaccination
- Provide verbal assurance that adequate birth control measures have been followed for 45 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3 months after the final vaccine/placebo vaccination. More information on this criterion can be found in the protocol.
- Body mass index (BMI) less than 30
Who cannot join
- Confirmed HIV-1 or HIV-2 infection
- Engaged in excessive daily alcohol use, frequent binge drinking, or illicit drug use within the 12 months prior to study entry
- History of new onset, sexually acquired infection, as determined by local, syndromic diagnostics standards or, as available, serologic and microbiologic diagnosis within the 12 months prior to study entry
- Has a known current high-risk partner or had such a partner within the 12 months prior to study entry
- Hepatitis B, hepatitis C, or syphilis infection; active syphilis documented by exam or serology unless positive serology is because of remote treated infection or positive rapid plasma reagin
- Pregnant, planning on becoming pregnant during the study, or breastfeeding
Show all 39Show fewer
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude study participation (e.g., history of seizure disorders, bleeding/clotting disorder, autoimmune disease, malignancy, tuberculosis, other systemic infections)
- Major surgery within the 4 weeks prior to study entry
- History of or known active heart disease including:
- Previous myocardial infarction (heart attack)
- Angina pectoris; congestive heart failure
- Valvular heart disease, including mitral valve prolapse
- Cardiomyopathy
- Myo/pericarditis
- Stroke or transient ischemic attack
- Chest pain or shortness of breath with activity (such as walking up stairs)
- Arrhythmia/episodic palpitations (not excluded: sinus arrhythmia)
- Pacemaker
- Other heart conditions under the care of a doctor
- People who have the following cardiac risk factors:
- Participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL
- First degree relative (e.g., mother, father, brother, sister) who had coronary artery disease before the age of 50 years
- Electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis. More information on this criterion can be found in the protocol.
- History of 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 12 months prior to study entry
- High blood pressure:
- If a person has been diagnosed with high blood pressure during screening or previously, exclude for high blood pressure that is not well controlled. More information on this criterion can be found in the protocol.
- If a person has NOT been diagnosed with high blood pressure during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at study entry or diastolic blood pressure greater than or equal to 100 mm Hg at study entry
- Major psychiatric illness and/or substance abuse problems during the 12 months before study entry that, in the opinion of the investigator, would preclude study participation
- Receipt of live attenuated vaccine within 30 days or inactivated/killed vaccine within 2 weeks of DNA vaccination
- Use of experimental therapeutic agents within 30 days of study entry
- Current or planned participation in another clinical study during the study period
- Receipt of blood products or immunoglobulin in the 3 months before study entry
- History of anaphylaxis or other serious adverse reactions to vaccines or egg products or amide type anesthetics (e.g., bupivacaine, novocaine, lidocaine, mepivacaine, neomycin, streptomycin)
- History of chronic urticaria (recurrent hives)
- Chronic or recurrent use of medications that modify host immune response (e.g., cancer chemotherapeutic agents, parenteral corticosteroids [topical not an exclusion])
- Recipient of an HIV vaccine candidate at any time and receipt of other experimental vaccine(s) within the 5 years before study entry. More information on this criterion can be found in the protocol.
- A study site employee
- Military personnel (will be excluded from participation in this study at all sites due to the potential for a false-positive HIV test result on mandatory HIV testing, which could have adverse affects on deployment status)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Rockville Vaccine Assessment Clinic (RVAC)
Rockville, Maryland, 20850
Kenya1 site
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, 20200
Tanzania1 site
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS
Mbeya
About this study
Official title: A Phase I Study of the Safety and Immunogenicity of PENNVAX-G DNA (ENV & GAG) Administered by Intramuscular Biojector 2000 or CELLECTRA Intramuscular Electroporation Device Followed by MVA-CMDR (HIV-1 CM235 ENV/CM240 GAG/POL) Boost in Healthy, HIV Uninfected Adults
The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.
Read the detailed description
Despite advances in treatment, HIV/AIDS rates remain high in low- and middle-income countries in resource-limited areas of the world. Preventive HIV vaccines would be an effective way to decrease the spread of HIV/AIDS. This study will evaluate an experimental HIV preventive vaccine followed by booster: the PENNVAX-G DNA vaccine and the Modified Vaccinia Ankara-Chiang Mai Double Recombinant (MVA-CMDR) booster vaccine. The MVA virus is a mild form of a vaccinia virus that is used in smallpox vaccines and does not cause smallpox infection. It has been safely used in vaccines for many years. Study researchers will examine if the combination of the two vaccines will provide an effective way for the body to build a defense against HIV. The PENNVAX-G vaccine will be administered to participants using one of two devices-the Biojector 2000 needleless device or the CELLECTRA intramuscular (IM) electroporation (EP) device-to evaluate how the immune response to the vaccine changes based on the device that is used. The purpose of this study is to evaluate the safety and immunogenicity of the PENNVAX-G vaccine, administered by either Biojector 2000 injection or CELLECTRA EP, followed by an MVA-CMDR vaccine boost, in healthy, HIV-uninfected adults.
This study will be conducted in two parts. Participants in the first part of the study will attend a baseline study visit, and they will undergo blood and urine collection, a medical history review, physical examination, and HIV testing counseling. All participants will receive the PENNVAX-G vaccine at baseline and Day 28. They will be randomly assigned to receive the vaccine by either the Bioinjector 2000 needleless device or the CELLECTRA IM EP device. On Days 84 and 168, all participants will receive the MVA-CMDR vaccine by IM injection delivered via needle and syringe. Participants will remain in the clinic for 1 hour after each vaccination for observation and vital sign monitoring, and they will record their temperatures and any symptoms in a diary for 7 days after each vaccination. Study staff will contact participants 1 to 2 days after each vaccination for follow-up monitoring. In addition to the vaccination study visits, participants will attend study visits at Weeks 1, 2, 4, 5, 6, 13, 14, 25, 26, 37, 50, and 52 and will repeat the baseline study procedures.
At the conclusion of the first part of the study, participants' study data will be reviewed and the safety of the vaccine regimen will be determined. If the regimen is found to be safe, then the second part of the study will begin. Participants in the second part of the study will be randomly assigned to receive the PENNVAX-G vaccine administered by either the Bioinjector 2000 device or the CELLECTRA EP device at baseline and Day 28, followed by the MVA-CDMR boost at Days 84 and 168, or they will receive placebo PENNVAX-G vaccine administered by either the Bioinjector 2000 device or the CELLECTRA EP device at baseline and Day 28, followed by a placebo MVA-CDMR boost at Days 84 and 168. All study visits and procedures that occurred during the first part of the study will also take place in the second part of the study.
Participants in the second part of the study will have the option of enrolling in a substudy. The purpose of the substudy is to evaluate the antibody response of the reproductive tract mucosa to the PENNVAX-G DNA, MVA-CDMR, and placebo vaccines administered in the main part of study. The substudy will also evaluate the effectiveness of using the Instead Softcup as a collection method to collect vaginal secretions for testing. Mucosal specimens and urine samples will be collected from participants at the screening visit and during the Week 2, 6, 14, 26, and 50 study visits.
- Conditions
- HIV Infections
- Being tested
- PENNVAX-G DNA Vaccine, MVA-CMDR Vaccine, Placebo PENNVAX-G Vaccine, Placebo MVA-CMDR Vaccine
- Keywords
- 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-G DNA VaccineBiological
PENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL
MVA-CMDR VaccineBiological
MVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid
Placebo PENNVAX-G VaccineBiological
Sodium Chloride Injection USP, 0.9%
Placebo MVA-CMDR VaccineBiological
Sodium Chloride Injection USP, 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive PENNVAX-G vaccine administered by intramuscular injection (IM) via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: PENNVAX-G DNA Vaccine; Biological: MVA-CMDR Vaccine |
| Group 2 | Experimental | Participants will receive PENNVAX-G vaccine administered via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: PENNVAX-G DNA Vaccine; Biological: MVA-CMDR Vaccine |
| Group 3: Subgroup 1 | Experimental | Participants will receive PENNVAX-G vaccine administered IM via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: PENNVAX-G DNA Vaccine; Biological: MVA-CMDR Vaccine |
| Group 3: Subgroup 2 | Placebo comparator | Participants will receive placebo vaccine for PENNVAX-G administered IM via Biojector 2000 needless device in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: Placebo PENNVAX-G Vaccine; Biological: Placebo MVA-CMDR Vaccine |
| Group 4: Subgroup 1 | Experimental | Participants will receive PENNVAX-G vaccine administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: PENNVAX-G DNA Vaccine; Biological: MVA-CMDR Vaccine |
| Group 4: Subgroup 2 | Placebo comparator | Participants will receive placebo vaccine for PENNVAX-G administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. Receives: Biological: Placebo PENNVAX-G Vaccine; Biological: Placebo MVA-CMDR Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe local toxicity at injection site
Measured: Measured after each vaccination
Severe systemic symptoms judged to be probably or definitely related to the vaccine
Measured: Measured after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- MAJ Julie Ake, MD, Study chair, U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260727
- Sponsor's protocol ID
- RV 262
- Other IDs
- 10793
- Status last verified
- Oct 2021
- First submitted
- 14 Dec 2010
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R. Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. doi: 10.1016/j.bbrc.2007.11.052. Epub 2007 Nov 26.
PubMed 18036339Loutfy MR, Harris M, Raboud JM, Antoniou T, Kovacs C, Shen S, Dufresne S, Smaill F, Rouleau D, Rachlis A, Gough K, Lalonde R, Tsoukas C, Trottier B, Walmsley SL, Montaner JS. A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007 Oct;8(7):427-32. doi: 10.1111/j.1468-1293.2007.00489.x.
PubMed 17760734Ake JA, Schuetz A, Pegu P, Wieczorek L, Eller MA, Kibuuka H, Sawe F, Maboko L, Polonis V, Karasavva N, Weiner D, Sekiziyivu A, Kosgei J, Missanga M, Kroidl A, Mann P, Ratto-Kim S, Anne Eller L, Earl P, Moss B, Dorsey-Spitz J, Milazzo M, Laissa Ouedraogo G, Rizvi F, Yan J, Khan AS, Peel S, Sardesai NY, Michael NL, Ngauy V, Marovich M, Robb ML. Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost. J Infect Dis. 2017 Nov 27;216(9):1080-1090. doi: 10.1093/infdis/jix456.
PubMed 28968759
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of PENNVAX-G DNA (ENV & GAG) Administered by Intramuscular Biojector 2000 or CELLECTRA Intramuscular Electroporation Device Followed by MVA-CMDR (HIV-1 CM235 ENV/CM240 GAG/POL) Boost in Healthy, HIV Uninfected Adults
- ClinicalTrials.gov ID
- NCT01260727
- Acronym / sponsor ID
- RV 262
- Conditions
- HIV Infections
- Keywords
- HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Dec 2010 (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 of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.
Detailed description
Despite advances in treatment, HIV/AIDS rates remain high in low- and middle-income countries in resource-limited areas of the world. Preventive HIV vaccines would be an effective way to decrease the spread of HIV/AIDS. This study will evaluate an experimental HIV preventive vaccine followed by booster: the PENNVAX-G DNA vaccine and the Modified Vaccinia Ankara-Chiang Mai Double Recombinant (MVA-CMDR) booster vaccine. The MVA virus is a mild form of a vaccinia virus that is used in smallpox vaccines and does not cause smallpox infection. It has been safely used in vaccines for many years. Study researchers will examine if the combination of the two vaccines will provide an effective way for the body to build a defense against HIV. The PENNVAX-G vaccine will be administered to participants using one of two devices-the Biojector 2000 needleless device or the CELLECTRA intramuscular (IM) electroporation (EP) device-to evaluate how the immune response to the vaccine changes based on the device that is used. The purpose of this study is to evaluate the safety and immunogenicity of the PENNVAX-G vaccine, administered by either Biojector 2000 injection or CELLECTRA EP, followed by an MVA-CMDR vaccine boost, in healthy, HIV-uninfected adults.
This study will be conducted in two parts. Participants in the first part of the study will attend a baseline study visit, and they will undergo blood and urine collection, a medical history review, physical examination, and HIV testing counseling. All participants will receive the PENNVAX-G vaccine at baseline and Day 28. They will be randomly assigned to receive the vaccine by either the Bioinjector 2000 needleless device or the CELLECTRA IM EP device. On Days 84 and 168, all participants will receive the MVA-CMDR vaccine by IM injection delivered via needle and syringe. Participants will remain in the clinic for 1 hour after each vaccination for observation and vital sign monitoring, and they will record their temperatures and any symptoms in a diary for 7 days after each vaccination. Study staff will contact participants 1 to 2 days after each vaccination for follow-up monitoring. In addition to the vaccination study visits, participants will attend study visits at Weeks 1, 2, 4, 5, 6, 13, 14, 25, 26, 37, 50, and 52 and will repeat the baseline study procedures.
At the conclusion of the first part of the study, participants' study data will be reviewed and the safety of the vaccine regimen will be determined. If the regimen is found to be safe, then the second part of the study will begin. Participants in the second part of the study will be randomly assigned to receive the PENNVAX-G vaccine administered by either the Bioinjector 2000 device or the CELLECTRA EP device at baseline and Day 28, followed by the MVA-CDMR boost at Days 84 and 168, or they will receive placebo PENNVAX-G vaccine administered by either the Bioinjector 2000 device or the CELLECTRA EP device at baseline and Day 28, followed by a placebo MVA-CDMR boost at Days 84 and 168. All study visits and procedures that occurred during the first part of the study will also take place in the second part of the study.
Participants in the second part of the study will have the option of enrolling in a substudy. The purpose of the substudy is to evaluate the antibody response of the reproductive tract mucosa to the PENNVAX-G DNA, MVA-CDMR, and placebo vaccines administered in the main part of study. The substudy will also evaluate the effectiveness of using the Instead Softcup as a collection method to collect vaginal secretions for testing. Mucosal specimens and urine samples will be collected from participants at the screening visit and during the Week 2, 6, 14, 26, and 50 study visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: PENNVAX-G DNA Vaccine, Biological: MVA-CMDR VaccineParticipants will receive PENNVAX-G vaccine administered by intramuscular injection (IM) via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
| Group 2 | Experimental | Biological: PENNVAX-G DNA Vaccine, Biological: MVA-CMDR VaccineParticipants will receive PENNVAX-G vaccine administered via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
| Group 3: Subgroup 1 | Experimental | Biological: PENNVAX-G DNA Vaccine, Biological: MVA-CMDR VaccineParticipants will receive PENNVAX-G vaccine administered IM via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
| Group 3: Subgroup 2 | Placebo comparator | Biological: Placebo PENNVAX-G Vaccine, Biological: Placebo MVA-CMDR VaccineParticipants will receive placebo vaccine for PENNVAX-G administered IM via Biojector 2000 needless device in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
| Group 4: Subgroup 1 | Experimental | Biological: PENNVAX-G DNA Vaccine, Biological: MVA-CMDR VaccineParticipants will receive PENNVAX-G vaccine administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
| Group 4: Subgroup 2 | Placebo comparator | Biological: Placebo PENNVAX-G Vaccine, Biological: Placebo MVA-CMDR VaccineParticipants will receive placebo vaccine for PENNVAX-G administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Low risk of HIV infection (as defined by the Study Risk Assessment Tool captured during the medical history)
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and committed to 18 months of follow-up contact
- Pass the Test of Understanding and demonstrate an understanding of STEP study results (HVTN 502/Merck 023 trial)
- Assessed by the clinic staff as being at low risk of HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment as follows: sexually abstinent, or had two or fewer mutually monogamous relationships with HIV-uninfected partners and who have not used illicit drugs, or had two or fewer partners believed to be HIV uninfected and who did not use illicit drugs and with whom he/she regularly uses condoms for sexual intercourse
- Healthy men and women (determined by medical history, physical examination, and clinical judgment)
Key exclusion criteria (39 listed)
- Confirmed HIV-1 or HIV-2 infection
- Engaged in excessive daily alcohol use, frequent binge drinking, or illicit drug use within the 12 months prior to study entry
- History of new onset, sexually acquired infection, as determined by local, syndromic diagnostics standards or, as available, serologic and microbiologic diagnosis within the 12 months prior to study entry
- Has a known current high-risk partner or had such a partner within the 12 months prior to study entry
- Hepatitis B, hepatitis C, or syphilis infection; active syphilis documented by exam or serology unless positive serology is because of remote treated infection or positive rapid plasma reagin
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-G DNA VaccinePENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL | Biological | Group 1, Group 2, Group 3: Subgroup 1, Group 4: Subgroup 1 |
| MVA-CMDR VaccineMVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid | Biological | Group 1, Group 2, Group 3: Subgroup 1, Group 4: Subgroup 1 |
| Placebo PENNVAX-G VaccineSodium Chloride Injection USP, 0.9% | Biological | Group 3: Subgroup 2, Group 4: Subgroup 2 |
| Placebo MVA-CMDR VaccineSodium Chloride Injection USP, 0.9% | Biological | Group 3: Subgroup 2, Group 4: Subgroup 2 |
Primary outcome
Severe local toxicity at injection site
Time frame: Measured after each vaccination
Severe systemic symptoms judged to be probably or definitely related to the vaccine
Time frame: Measured after each vaccination
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 1 Nov 2021.
- Background: PubMed 18036339Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R. Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. doi: 10.1016/j.bbrc.2007.11.052. Epub 2007 Nov 26.
- Background: PubMed 17760734Loutfy MR, Harris M, Raboud JM, Antoniou T, Kovacs C, Shen S, Dufresne S, Smaill F, Rouleau D, Rachlis A, Gough K, Lalonde R, Tsoukas C, Trottier B, Walmsley SL, Montaner JS. A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007 Oct;8(7):427-32. doi: 10.1111/j.1468-1293.2007.00489.x.
- Derived from this study: PubMed 28968759Ake JA, Schuetz A, Pegu P, Wieczorek L, Eller MA, Kibuuka H, Sawe F, Maboko L, Polonis V, Karasavva N, Weiner D, Sekiziyivu A, Kosgei J, Missanga M, Kroidl A, Mann P, Ratto-Kim S, Anne Eller L, Earl P, Moss B, Dorsey-Spitz J, Milazzo M, Laissa Ouedraogo G, Rizvi F, Yan J, Khan AS, Peel S, Sardesai NY, Michael NL, Ngauy V, Marovich M, Robb ML. Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost. J Infect Dis. 2017 Nov 27;216(9):1080-1090. doi: 10.1093/infdis/jix456.
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People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
MAJ Julie Ake, MD study chair
U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PENNVAX-G DNA Vaccine and MVA-CMDR Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 4 countries.
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 19 inclusion and 39 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Kenya, Tanzania, Uganda. 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. 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 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?
Severe local toxicity at injection site (time frame: Measured after each vaccination). The study lists 2 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 NCT01260727, which also lists 3 linked publications.
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 1 Nov 2021.