Evaluating the Safety and Immune Response to Two Pneumococcal Vaccines in HIV-Infected Pregnant Women

This is an interventional prevention trial for Pneumococcal Infections Read More

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