Eligibility |
Inclusion Criteria for Step 1:
- 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
Exclusion Criteria for Step 1:
- 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
- Receipt of IL2, interferon (IFN), granulocyte-macrophage colony-stimulating factor
(GMCSF) or other immune mediators less than or equal to 12 weeks before study entry
- Malaria during current pregnancy or other chronic disease (other than HIV) known to
decrease transplacental transfer of antibodies
- Uncontrolled major psychiatric disorder
- History of a severe adverse reaction to inactivated polysaccharide or conjugated
vaccines
- Any condition that would, in the opinion of the site investigator, place the
participant at an unacceptable risk of injury or render the person unable to meet the
requirements of the study
- Pregnancy complications (in the current pregnancy) such as pre-term labor,
hypertension (systolic blood pressure greater than or equal to 140 mm Hg and/or
diastolic blood pressure greater than or equal to 90 mm Hg), and pre-eclampsia or any
other pregnancy-related complication, which in the opinion of the investigator, might
jeopardize the results of the study
Inclusion Criteria for Step 2:
- 24 weeks postpartum
- Completion of Step 1 of the study
Exclusion Criteria for Step 2:
- Pregnancy
- Receipt of any live licensed vaccine less than or equal to 4 weeks prior to entry or
receipt of inactivated licensed vaccine less than or equal to 2 weeks prior to 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, or expects to receive
another non-licensed agent within 30 days after vaccination
- Any significant (in the opinion of the site investigator) acute illness and/or oral
temperature greater than or equal to 100.0 degrees Fahrenheit within 24 hours except
when, in the opinion of the physician, withholding the agent entails even greater risk
- Use of anti-cancer systemic chemotherapy or radiation therapy or has developed
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)
- 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
2 weeks of entry in step 2. In some cases, entry in step can be delayed to avoid this
exclusion criterion.
- Receipt of immunoglobulin or other blood products (with exception of Rho D immune
globulin) within 12 weeks prior to entry in step 2 or is scheduled to receive
immunoglobulin or other blood products (with the exception of Rho D immune globulin)
during the 30 days following vaccination
- Receipt of IL2, interferon (IFN), granulocyte-macrophage colony-stimulating factor
(GMCSF), or other immune mediators less than or equal to 12 weeks before entry in step
2
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