HIV InfectionsPhase 1NCT00098163
Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
A Phase 1 study testing ALVAC-HIV vCP1521 and ALVAC HIV-1 vCP1521 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- ALVAC-HIV vCP1521 and ALVAC HIV-1 vCP1521
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUganda
- Study dates
- Start not givento May 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV infected
- In third trimester of pregnancy
- CD4 count of more than 500 cells/mm3 at screening
- Intends to give birth at Mulago Hospital, Uganda
- Willing to be taken home by a home visitor after delivery to document locator information and willing to be visited at home later
- 3 or fewer days of age
- Born to an HIV infected woman eligible for the study
- Weight at birth at least 2000 g (4.4 lbs)
Who cannot join
- Prior participation in an HIV-1 vaccine trial
- Investigational agents, blood products, immunoglobulin, or immunotherapy any time during this pregnancy
- Documented or suspected serious medical illness or life-threatening condition that may interfere with the study
- Multiple birth predicted in current pregnancy
- Mother left study prior to infant enrollment and randomization
- Mother or infant received any active or passive HIV immunotherapy or investigational product other than the study vaccine. Mothers and infants who have taken nevirapine prior to study entry are not excluded.
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- Blood products, immunoglobulin, or immunosuppressive therapy during labor and delivery or prior to study enrollment
- Abnormal vital signs prior to vaccination or clinical symptoms that may interfere with vaccine reaction assessment
- Part of a multiple birth
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala
About this study
Official title: A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.
Read the detailed description
Mother-to-child transmission (MTCT) of HIV can be caused either by perinatal transmission of HIV or by breastfeeding, a common practice in poorer regions of the world. HIV preventive vaccines are currently under investigation as potential solutions to worldwide MTCT of HIV. This study will evaluate the safety and immunogenicity of an HIV-1 vaccine, ALVAC-HIV vCP1521, in infants born to HIV-1 infected mothers in Uganda. The vaccine is a preparation of a live attenuated recombinant canarypox virus, encoding HIV clades B and E envelope proteins. This study will be conducted at Mulago Hospital in Uganda.
Mothers will enroll in this study during their third trimesters of pregnancy. During screening, mothers will undergo medical history assessment, a physical exam, and blood collection. After delivery and prior to infant enrollment, mothers will have another physical exam; mothers and their infants will be accompanied home by a home visitor who will document contact information.
Infants will be followed for 24 months after birth. Infants will be randomly assigned to receive 4 injections of vaccine or placebo. Study injections will be given at the start of the study and at Weeks 4, 8, and 12. Infants will be observed for 1 hour after each vaccine administration to check for body temperature and local and systemic reactions. They will also be evaluated in the clinic the day after each immunization for any local or systemic reactions. Infants will be visited at home 2 days after vaccine administration by a trained study nurse who will assess reactogenicity. Blood will be collected at 9 selected times: study entry, Weeks 2, 6, 10, and 14, and Months 6, 12, 18, and 24. Sixteen study visits occurring over 2 years will include medical history assessment and physical exams. Childhood immunizations will be given to infants at study entry and at Weeks 6, 10, and 14 and Months 6 and 12.
- Conditions
- HIV Infections
- Being tested
- ALVAC-HIV vCP1521, ALVAC HIV-1 vCP1521
- 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.
ALVAC-HIV vCP1521Biological
One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12.
ALVAC HIV-1 vCP1521Biological
One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: ALVAC-HIV vCP1521 |
| 2 | Placebo comparator | Not described Receives: Biological: ALVAC HIV-1 vCP1521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated
Measured: At Day 0 and throughout study
Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens
Measured: At Day 0 and throughout study
Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay
Measured: At Day 0 and throughout study
Secondary outcomes (2)
Immune status as measured by CD4 cell counts in all immunized infants
Measured: Over the 24-month follow-up period
Development of immunity to routine vaccination as measured by antibody levels and Bacillus Calmette-Guéerin (BCG) scar formation
Measured: At the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2004 (estimated)
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Laura Guay, MD, Study chair, Department of Pathology, Johns Hopkins UniversityFrancis Mmiro, MBChB, FRCOG, Study chair, Department of Obstetrics and Gynecology, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098163
- Sponsor's protocol ID
- HPTN 027
- Other IDs
- 10141
- Status last verified
- Oct 2021
- First submitted
- 3 Dec 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Cao H, Mani I, Vincent R, Mugerwa R, Mugyenyi P, Kanki P, Ellner J, Walker BD. Cellular immunity to human immunodeficiency virus type 1 (HIV-1) clades: relevance to HIV-1 vaccine trials in Uganda. J Infect Dis. 2000 Nov;182(5):1350-6. doi: 10.1086/315868. Epub 2000 Oct 9.
PubMed 11023458de Bruyn G, Rossini AJ, Chiu YL, Holman D, Elizaga ML, Frey SE, Burke D, Evans TG, Corey L, Keefer MC. Safety profile of recombinant canarypox HIV vaccines. Vaccine. 2004 Jan 26;22(5-6):704-13. doi: 10.1016/j.vaccine.2003.08.023.
PubMed 14741163Franchini G, Gurunathan S, Baglyos L, Plotkin S, Tartaglia J. Poxvirus-based vaccine candidates for HIV: two decades of experience with special emphasis on canarypox vectors. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S75-88. doi: 10.1586/14760584.3.4.s75.
PubMed 15285707Safrit JT, Ruprecht R, Ferrantelli F, Xu W, Kitabwalla M, Van Rompay K, Marthas M, Haigwood N, Mascola JR, Luzuriaga K, Jones SA, Mathieson BJ, Newell ML; Ghent IAS Working Group on HIV in Women Children. Immunoprophylaxis to prevent mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):169-77. doi: 10.1097/00126334-200402010-00012.
PubMed 14722451Kaleebu P, Njai HF, Wang L, Jones N, Ssewanyana I, Richardson P, Kintu K, Emel L, Musoke P, Fowler MG, Ou SS, Jackson JB, Guay L, Andrew P, Baglyos L, Cao H; HPTN 027 protocol team. Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):268-77. doi: 10.1097/01.qai.0000435600.65845.31.
PubMed 24091694Kintu K, Andrew P, Musoke P, Richardson P, Asiimwe-Kateera B, Nakyanzi T, Wang L, Fowler MG, Emel L, Ou SS, Baglyos L, Gurunathan S, Zwerski S, Jackson JB, Guay L. Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa. J Acquir Immune Defic Syndr. 2013 May 1;63(1):1-8. doi: 10.1097/QAI.0b013e31827f1c2d.
PubMed 23221981
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 to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
- ClinicalTrials.gov ID
- NCT00098163
- Acronym / sponsor ID
- HPTN 027
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study completion
- May 2009 (actual)
- First posted
- 6 Dec 2004 (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 test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.
Detailed description
Mother-to-child transmission (MTCT) of HIV can be caused either by perinatal transmission of HIV or by breastfeeding, a common practice in poorer regions of the world. HIV preventive vaccines are currently under investigation as potential solutions to worldwide MTCT of HIV. This study will evaluate the safety and immunogenicity of an HIV-1 vaccine, ALVAC-HIV vCP1521, in infants born to HIV-1 infected mothers in Uganda. The vaccine is a preparation of a live attenuated recombinant canarypox virus, encoding HIV clades B and E envelope proteins. This study will be conducted at Mulago Hospital in Uganda.
Mothers will enroll in this study during their third trimesters of pregnancy. During screening, mothers will undergo medical history assessment, a physical exam, and blood collection. After delivery and prior to infant enrollment, mothers will have another physical exam; mothers and their infants will be accompanied home by a home visitor who will document contact information.
Infants will be followed for 24 months after birth. Infants will be randomly assigned to receive 4 injections of vaccine or placebo. Study injections will be given at the start of the study and at Weeks 4, 8, and 12. Infants will be observed for 1 hour after each vaccine administration to check for body temperature and local and systemic reactions. They will also be evaluated in the clinic the day after each immunization for any local or systemic reactions. Infants will be visited at home 2 days after vaccine administration by a trained study nurse who will assess reactogenicity. Blood will be collected at 9 selected times: study entry, Weeks 2, 6, 10, and 14, and Months 6, 12, 18, and 24. Sixteen study visits occurring over 2 years will include medical history assessment and physical exams. Childhood immunizations will be given to infants at study entry and at Weeks 6, 10, and 14 and Months 6 and 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ALVAC-HIV vCP1521 |
| 2 | Placebo comparator | Biological: ALVAC HIV-1 vCP1521 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV infected
- In third trimester of pregnancy
- CD4 count of more than 500 cells/mm3 at screening
- Intends to give birth at Mulago Hospital, Uganda
- Willing to be taken home by a home visitor after delivery to document locator information and willing to be visited at home later
Key exclusion criteria (9 listed)
- Prior participation in an HIV-1 vaccine trial
- Investigational agents, blood products, immunoglobulin, or immunotherapy any time during this pregnancy
- Documented or suspected serious medical illness or life-threatening condition that may interfere with the study
- Multiple birth predicted in current pregnancy
- Mother left study prior to infant enrollment and randomization
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 |
|---|---|---|
| ALVAC-HIV vCP1521One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12. | Biological | 1 |
| ALVAC HIV-1 vCP1521One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12. | Biological | 2 |
Primary outcome
Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated
Time frame: At Day 0 and throughout study
Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens
Time frame: At Day 0 and throughout study
Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay
Time frame: At Day 0 and throughout study
2 secondary outcomes
Immune status as measured by CD4 cell counts in all immunized infants
Time frame: Over the 24-month follow-up period
Development of immunity to routine vaccination as measured by antibody levels and Bacillus Calmette-Guéerin (BCG) scar formation
Time frame: At the end of 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 1 Nov 2021.
- Background: PubMed 11023458Cao H, Mani I, Vincent R, Mugerwa R, Mugyenyi P, Kanki P, Ellner J, Walker BD. Cellular immunity to human immunodeficiency virus type 1 (HIV-1) clades: relevance to HIV-1 vaccine trials in Uganda. J Infect Dis. 2000 Nov;182(5):1350-6. doi: 10.1086/315868. Epub 2000 Oct 9.
- Background: PubMed 14741163de Bruyn G, Rossini AJ, Chiu YL, Holman D, Elizaga ML, Frey SE, Burke D, Evans TG, Corey L, Keefer MC. Safety profile of recombinant canarypox HIV vaccines. Vaccine. 2004 Jan 26;22(5-6):704-13. doi: 10.1016/j.vaccine.2003.08.023.
- Background: PubMed 15285707Franchini G, Gurunathan S, Baglyos L, Plotkin S, Tartaglia J. Poxvirus-based vaccine candidates for HIV: two decades of experience with special emphasis on canarypox vectors. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S75-88. doi: 10.1586/14760584.3.4.s75.
- Background: PubMed 14722451Safrit JT, Ruprecht R, Ferrantelli F, Xu W, Kitabwalla M, Van Rompay K, Marthas M, Haigwood N, Mascola JR, Luzuriaga K, Jones SA, Mathieson BJ, Newell ML; Ghent IAS Working Group on HIV in Women Children. Immunoprophylaxis to prevent mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):169-77. doi: 10.1097/00126334-200402010-00012.
- Derived from this study: PubMed 24091694Kaleebu P, Njai HF, Wang L, Jones N, Ssewanyana I, Richardson P, Kintu K, Emel L, Musoke P, Fowler MG, Ou SS, Jackson JB, Guay L, Andrew P, Baglyos L, Cao H; HPTN 027 protocol team. Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):268-77. doi: 10.1097/01.qai.0000435600.65845.31.
- Derived from this study: PubMed 23221981Kintu K, Andrew P, Musoke P, Richardson P, Asiimwe-Kateera B, Nakyanzi T, Wang L, Fowler MG, Emel L, Ou SS, Baglyos L, Gurunathan S, Zwerski S, Jackson JB, Guay L. Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa. J Acquir Immune Defic Syndr. 2013 May 1;63(1):1-8. doi: 10.1097/QAI.0b013e31827f1c2d.
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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.
Laura Guay, MD study chair
Department of Pathology, Johns Hopkins University
Francis Mmiro, MBChB, FRCOG study chair
Department of Obstetrics and Gynecology, Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALVAC-HIV vCP1521 and ALVAC HIV-1 vCP1521 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
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 8 inclusion and 9 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 1 site in 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?
Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated (time frame: At Day 0 and throughout study). The study lists 3 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 NCT00098163, which also lists 6 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.