HIV InfectionsPhase 1NCT00001041
Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
A Phase 1 study testing rgp120/HIV-1MN in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- rgp120/HIV-1MN
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento Jul 1998
- 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:
- AZT.
- Acyclovir.
- Patients must have:
- HIV-1 infection.
Show all 11Show fewer
- CD4 count >= 400 cells/mm3.
- No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
- HIV p24 < 30 pg/ml.
- Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks.
- Concurrent AZT therapy is permitted.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity to a component of the vaccine.
- Evidence of fetal abnormality on ultrasound.
- Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
- Active syphilis.
Show all 14Show fewer
- Hepatitis B surface antigen positive.
- Concurrent Medication:
- Excluded:
- Antiretroviral or immunomodulating agent other than AZT during the pregnancy.
- Prior Medication:
- Excluded:
- Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry.
- Current use of illicit drugs or known chronic alcohol use.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
San Francisco Gen. Hosp.
San Francisco, California, 941102859
UCSF Pediatric AIDS CRS
San Francisco, California
Washington U CRS
St Louis, Missouri, 63104
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
About this study
To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants. To evaluate the induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected infants.
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Read the detailed description
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of five injections. Patients may have optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and infants are followed through 18 months after delivery. Per 06/94 addendum, patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are discontinued.
- Conditions
- HIV Infections, Pregnancy
- Being tested
- rgp120/HIV-1MN
- Keywords
- Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections, Pregnancy Complications, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rgp120/HIV-1MNBiological
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)
- Study completionJul 1998
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
- Intervention model
- Parallel groups
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wara DW, Study chairLambert JS, Study chairWright PF, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001041
- Sponsor's protocol ID
- ACTG 235
- Other IDs
- AVEG 104, 11212
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Hompe ED, Mangold JF, Kumar A, Eudailey JA, McGuire E, Haynes BF, Moody MA, Wright PF, Fouda GG, Giorgi EE, Gao F, Permar SR. Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials. mSphere. 2020 Jun 3;5(3):e00254-20. doi: 10.1128/mSphere.00254-20.
PubMed 32493720
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-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
- ClinicalTrials.gov ID
- NCT00001041
- Acronym / sponsor ID
- ACTG 235
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 1998 (actual)
- 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.
To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants. To evaluate the induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected infants.
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Detailed description
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of five injections. Patients may have optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and infants are followed through 18 months after delivery. Per 06/94 addendum, patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are discontinued.
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 (11 listed)
- AZT.
- Acyclovir.
- HIV-1 infection.
- CD4 count >= 400 cells/mm3.
- No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
Key exclusion criteria (14 listed)
- Known hypersensitivity to a component of the vaccine.
- Evidence of fetal abnormality on ultrasound.
- Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
- Active syphilis.
- Hepatitis B surface antigen positive.
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 |
|---|---|---|
| rgp120/HIV-1MN | Biological | – |
Primary outcome
Not reported in the source record.
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.
- Derived from this study: PubMed 32493720Hompe ED, Mangold JF, Kumar A, Eudailey JA, McGuire E, Haynes BF, Moody MA, Wright PF, Fouda GG, Giorgi EE, Gao F, Permar SR. Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials. mSphere. 2020 Jun 3;5(3):e00254-20. doi: 10.1128/mSphere.00254-20.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
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.
Wara DW study chair
Lambert JS study chair
Wright PF study chair
6 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 rgp120/HIV-1MN in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 11 inclusion and 14 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 6 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001041, 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 1 Nov 2021.