HIV InfectionsPhase 1NCT00001046
Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
A Phase 1 study testing MF59 and rgp120/HIV-1 SF-2 in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women. SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- HIV Infections, Pregnancy, HIV Seronegativity
- What is being tested?
- MF59 and rgp120/HIV-1 SF-2
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concurrent Medication:
- Allowed during pregnancy:
- AZT.
- Methadone maintenance.
- NOTE:
- Patients may not initiate antiretroviral therapy for disease progression.
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- NOTE:
- Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
- Patients must have:
- Documented HIV infection.
- CD4 count >= 400 cells/mm3 (average of two determinations obtained 1 week apart).
- No clinical criteria for a diagnosis of AIDS.
- HIV p24 antigen <= 30 pg/ml.
- Estimated gestational age between 16 and 24 weeks, confirmed by baseline sonogram that does not demonstrate any congenital abnormalities considered to be incompatible with life.
- Intention to carry pregnancy to term.
- Willingness to be followed by an ACTU for the duration of the study.
- NOTE:
- Father of the fetus (if available after a reasonable attempt to contact him) must provide informed consent.
- Prior Medication:
- Allowed:
- AZT.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to a component of the vaccine.
- Hepatitis B antigen positive at study entry.
- Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome).
- Evidence of syphilis that requires therapy during this pregnancy.
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- Intention to breast-feed.
- Presence of obstetrical high-risk factors such as:
- insulin-dependent diabetes
- hypertension requiring the use of anti-hypertensive therapy
- repeated intrauterine fetal demise
- Rh-sensitization or other blood group alloimmunization
- diseases requiring use of immunosuppressive therapy (e.g., asthma, lupus).
- Concurrent Medication:
- Excluded during pregnancy:
- Antiretrovirals other than AZT.
- Immunomodulating agents (e.g., HIVIG, IVIG).
- Other investigational drugs or immunosuppressive agents.
- NOTE:
- Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
- Prior Medication:
- Excluded within 90 days prior to study entry:
- Antiretrovirals other than AZT.
- Immunomodulating agents (e.g., HIVIG, IVIG).
- Current use of illicit drugs or chronic alcohol use by patient history.
About this study
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women.
SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy.
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Read the detailed description
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
- Conditions
- HIV Infections, Pregnancy, HIV Seronegativity
- Being tested
- MF59, rgp120/HIV-1 SF-2
- Keywords
- Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, AIDS-Related Complex, HIV Envelope Protein gp120, HIV Preventive Vaccine, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59Biological
rgp120/HIV-1 SF-2Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Starr S, Study chairAllen M, Study chairScott GB, Study chairSilverman N, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001046
- Sponsor's protocol ID
- ACTG 233
- Other IDs
- 11210
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
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
- Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
- ClinicalTrials.gov ID
- NCT00001046
- Acronym / sponsor ID
- ACTG 233
- Conditions
- HIV Infections, Pregnancy, HIV Seronegativity
- Keywords
- Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, AIDS-Related Complex, HIV Envelope Protein gp120, HIV Preventive Vaccine, HIV Therapeutic Vaccine
- 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
- First posted
- 31 Aug 2001 (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.
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women.
SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy.
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Detailed description
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- AZT.
- Methadone maintenance.
- Patients may not initiate antiretroviral therapy for disease progression.
- Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
- Documented HIV infection.
Key exclusion criteria (25 listed)
- Known hypersensitivity to a component of the vaccine.
- Hepatitis B antigen positive at study entry.
- Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome).
- Evidence of syphilis that requires therapy during this pregnancy.
- Intention to breast-feed.
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 |
|---|---|---|
| MF59 | Biological | – |
| rgp120/HIV-1 SF-2 | Biological | – |
Primary outcome
Not reported in the source record.
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 1 Nov 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.
Starr S study chair
Allen M study chair
Scott GB study chair
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MF59 and rgp120/HIV-1 SF-2 in people with HIV Infections and Pregnancy, 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 21 inclusion and 25 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 1 Nov 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.
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 1 Nov 2021.