Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

Step 1 Inclusion Criteria for Pregnant Women:

• Pregnant women ≥ 18 years old who provided written informed consent prior to study initiation.
• Pregnant women 50, 000/mm3 and an absolute neutrophil count (ANC) of > 500/ mm3 ≤ 28 days prior to study entry.
• Women who were willing and able to comply with the study visits.

Step 1 Exclusion Criteria for Pregnant Women:

• Receipt of any PCV or PPV-23 at any time prior to enrollment, documented by medical history or record.
• Receipt of any live licensed vaccine ≤ 4 weeks or inactivated licensed vaccine ≤ 2 weeks prior to study entry.
• Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 4 weeks prior to enrollment in this study, or expectations to receive another non-licensed agent before delivery unless approval from the protocol team is obtained.
• Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 100.4 degrees F ≤ 24 hours prior to study entry.
• Women who planed to terminate their pregnancy.
• Women who had a prior history of lupus or other autoimmune disorders.
• Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or evidence of immunosuppression as a result of an underlying illness (other than HIV-1 infection) or treatment.
• Ongoing neoplastic disease (excluding non-melanoma skin cancer, and human papilloma virus-related cervical dysplasia, cervical intraepithelial neoplasia (CIN) grades 1, 2 or 3).
• Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 12 weeks of study entry.
• Women who received last dose of corticosteroids for preterm labor ≤ 1 week prior to study entry. Note: A woman can be enrolled if more than 1 week has elapsed from the last dose of corticosteroids, i.e., enrollment may be delayed to satisfy this criterion.
• Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment 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 Interleukin-2 (IL2), interferon (IFN), granulocyte-macrophage colony-stimulating factor (GMCSF) or other immune mediators ≤ 12 weeks before enrollment.
• 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 participant unable to meet the requirements of the protocol.
• Pregnancy complications (in the current pregnancy) such as pre-term labor, and pre-eclampsia or any other pregnancy related complication, which in the opinion of the investigator might jeopardize the results of the study.
• Chronic hepatitis B infection that may require administration of Hepatitis B Hyperimmune Globulin to neonates.

Step 2 Inclusion Criteria for Women:

• 24 weeks ± 4 weeks postpartum.
• Completion of Step 1.
• Receipt of placebo on Step 1.

Step 2 Exclusion Criteria for Women:

• Pregnancy.
• Receipt of any live licensed vaccine ≤ 4 weeks or inactivated licensed vaccine ≤ 2 weeks prior to Step 2 entry.
• Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 4 weeks prior to vaccination, or expects to receive another non-licensed agent within 28 days after vaccination.
• Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 100.4 degrees F within 24 hours of entry 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 o