Evaluating the Safety and Immune Response to Two Pneumococcal Vaccines in HIV-Infected Pregnant Women
Administration of Polysaccharide or Conjugated Pneumococcal Vaccines to HIV-Infected Pregnant Women: Safety and Magnitude, Persistence, and Transplacental Transfer of Vaccine-Serotype Pneumococcal Anti-Capsular Antibodies
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
HIV-infected people and pregnant women are at risk of developing severe pneumococcal disease. The purpose of this study is to compare the safety and immune response to two pneumococcal vaccines in HIV-infected pregnant women.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedNovember 1, 2021
October 1, 2021
September 27, 2011
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (11)
For women: Grade 3 or higher adverse events
Measured through approximately 60 weeks
For women: Grade 3 or higher adverse events judged to be at least possibly related to the study treatment
Measured through approximately 60 weeks
For women: A 2-fold increase in ELISA or 4-fold rise in opsonic activity (OPA)-measured antibody concentrations
IgG antibodies to pneumococcal (PNC) 19A, 6B, 18C, and 5 will be measured by enzyme-linked immunosorbent assay (ELISA) and the capacity to opsonize to 19A and 6B will also be measured by OPA. The primary endpoint is a response to 3 out of 4 serotypes. A greater than or equal to 4-fold increase in OPA- and/or a greater than or equal to 2-fold increase in ELISA-measured IgG antibodies against PNC 19A and 6B will define a response against these serotypes. Responses to PNC 18C and 5 will rely only on the ELISA results.
Measured at 14 to 21 days after immunization
For infants: ELISA-measured IgG antibody levels greater than or equal to 0.35ug/mL or OPA-measured antibody titers greater than or equal to 1:8
Reaching this level of antibodies for 3 of the 4 PNC serotypes that will be tested defines success
Measured at 8 weeks of age for infants
For women: Pneumonia or invasive pneumococcal disease
Measured through approximately 60 weeks
For women: Grade 3 or higher pregnancy-specific systemic adverse events
Measured through approximately 60 weeks
For women: Significant changes in HIV viral load in pregnant participants
Measured through approximately 60 weeks
For infants: Congenital defects
Measured through approximately 36 weeks
For infants: Pneumonia or invasive pneumococcal disease
Measured through approximately 36 weeks
For infants: In-utero or perinatal HIV infection
Measured through approximately 36 weeks
For infants: Immune interference with infant response to PCV vaccine
Measured through approximately 36 weeks
Secondary Outcomes (2)
Infant maternal antibodies at 2 months of life
Measured at 2 months of age for infants
Maternal and infant vitamin D levels
Measured through approximately 60 weeks
Study Arms (5)
Step 1: PPV-23 Vaccine (Arm 1a)
EXPERIMENTALParticipants will receive one intramuscular (IM) injection of 0.5 mL of the PPV-23 vaccine at baseline.
Step 1: PCV-13 Vaccine (Arm 1b)
EXPERIMENTALParticipants will receive one IM injection of 0.5 mL of the PCV-13 vaccine at baseline.
Step 1: Placebo Vaccine (Arm 1c)
PLACEBO COMPARATORParticipants will receive one IM injection of 0.5 mL of the placebo vaccine at baseline.
Step 2: PPV-23 Vaccine (Arm 2a)
EXPERIMENTALParticipants will receive one IM injection of 0.5 mL of the PPV-23 vaccine 6 months after delivery.
Step 2: PCV-13 Vaccine (Arm 2b)
EXPERIMENTALParticipants will receive one IM injection of 0.5 mL of the PCV-13 vaccine 6 months after delivery.
Interventions
Administered as a 0.5 mL IM dose
Administered as a 0.5 mL IM dose
Eligibility Criteria
You may qualify if:
- Pregnant women 18 to 39 years old who provide written informed consent prior to initiation of study
- Pregnant women 13 to less than 18 years old with a parent or legal guardian able and willing to provide signed informed consent or who have attained the minimum age of consent, as defined by the local Institutional Review Board (IRB), and who provide written informed consent prior to initiation of study
- Gestational age (greater than or equal to 15 weeks \[15 weeks 0 days\] to less than 33 weeks \[32 weeks 6 days\]) documented by the approximate date of the last menstrual period and corroborated by physical exam. Ultrasound will be performed at sites where it is available to confirm or correct gestational dates prior to immunization.
- Documentation of HIV-1 infection defined as positive results from two samples collected at different time points. The same method may be used at both time points. All samples tested must be whole blood, serum, or plasma. More information on this criterion can be found in the protocol.
- Receipt of highly active antiretroviral therapy (HAART) for greater than or equal to 4 weeks prior to study entry; see World Health Organization (WHO) advice: http://www.who.int/hiv/pub/mtct/advice/en/index.html
- Documented platelet count of greater than 50,000/mm\^3 and an absolute neutrophil count (ANC) of greater than 500/mm\^3 less than or equal to 28 days prior to study entry
- Able to understand and comply with planned study procedures
- Women who are willing and able to comply with the study visits
You may not qualify if:
- Receipt of PCV at any time prior to study entry documented by medical history or record
- Receipt of PPV-23 at any time prior to enrollment documented by medical history or record
- Receipt of any live licensed vaccine less than or equal to 4 weeks or inactivated licensed vaccine less than or equal to 2 weeks prior to study entry
- Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) less than or equal to 4 weeks prior to vaccination in this study, or expects to receive another non-licensed agent before delivery unless study approval is obtained
- Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 100.0 degrees Fahrenheit less than or equal to 24 hours prior to study entry
- Women who have virologic failure and ineffective ARV therapy as indicated by an increase in plasma HIV RNA copies/ml greater than 3-fold between initiation of HAART and the most recent prenatal visit
- Women who do not agree to be compliant with antiretroviral therapy during pregnancy
- Women who plan to terminate their pregnancy
- Women who have a documented prior history of stillbirth, persistent hypertension, preeclampsia, preterm premature rupture of the membranes less than 32 weeks gestation, oligohydramnios, lupus, HELP syndrome, or obstetric cholestasis
- Any women, who in the opinion of the investigator has a serious cardiovascular or pulmonary function disease and in whom a systemic reaction would pose a significant risk
- Use of anti-cancer systemic chemotherapy or radiation therapy less than or equal to 48 weeks prior to study entry, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
- Ongoing neoplastic disease (excluding non-melanoma skin cancer, human papilloma virus \[HPV\]-related cervical dysplasia, and cervical intraepithelial neoplasia \[CIN\] Grades 1, 2, or 3)
- Long-term use of glucocorticoids, including oral or parenteral prednisone greater than or equal to 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 12 weeks of study entry, or high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) less than or equal to 12 weeks before study entry (nasal and topical steroids are allowed)
- Women who received corticosteroids for preterm labor less than or equal to 2 weeks before study entry
- Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) less than or equal to 12 weeks prior to study entry in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Scott JA, Brooks WA, Peiris JS, Holtzman D, Mulholland EK. Pneumonia research to reduce childhood mortality in the developing world. J Clin Invest. 2008 Apr;118(4):1291-300. doi: 10.1172/JCI33947.
PMID: 18382741BACKGROUNDLopez-Palomo C, Martin-Zamorano M, Benitez E, Fernandez-Gutierrez C, Guerrero F, Rodriguez-Iglesias M, Giron-Gonzalez JA. Pneumonia in HIV-infected patients in the HAART era: incidence, risk, and impact of the pneumococcal vaccination. J Med Virol. 2004 Apr;72(4):517-24. doi: 10.1002/jmv.20045.
PMID: 14981752BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adriana Weinberg, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2011
First Posted
September 29, 2011
Primary Completion
August 1, 2014
Last Updated
November 1, 2021
Record last verified: 2021-10