Pneumococcal InfectionsPhase 2NCT01443117
Evaluating the Safety and Immune Response to Two Pneumococcal Vaccines in HIV-Infected Pregnant Women
A Phase 2 study testing PPV-23 Vaccine and PCV-13 Vaccine in people with Pneumococcal Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 39 years, women only
- Conditions the study is for
- Pneumococcal Infections, HIV Infections
- What is being tested?
- PPV-23 Vaccine and PCV-13 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Aug 2014
- Phase
- Phase 2
- 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 13 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- Able to understand and comply with planned study procedures
- Women who are willing and able to comply with the study visits
- 24 weeks postpartum
- Completion of Step 1 of the study
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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
About this study
Official title: 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
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.
Read the detailed description
Pneumococcus is the most common bacterial opportunistic infection in HIV-infected children, and it is the leading cause of bacterial pneumonias in HIV-infected pregnant and non-pregnant adults. Pneumococcal polysaccharide vaccine (PPV-23) and pneumococcal conjugate vaccine (PCV-13) are two vaccines used for the prevention of pneumococcal (PNC) disease. The PPV-23 vaccine is recommended by the Centers for Disease Control and Prevention (CDC) for HIV-infected adults, including HIV-infected pregnant women. The PCV-13 vaccine is recommended by the CDC for use in children, including HIV-infected children. Studies have shown that PCV-13 and vaccines like PCV-13 are safe for use in healthy pregnant women, but they have not been studied in HIV-infected pregnant women. This study will compare the safety and immune response to the PCV-13 and PPV-23 vaccines in HIV-infected pregnant women.
This study will enroll HIV-infected pregnant women in their second or third trimester who are receiving antiretroviral therapy. The study will take place in two steps. In Step 1, participants will be randomly assigned to receive PPV-23 vaccine, PCV-13 vaccine, or placebo vaccine. At a baseline study visit, participants will undergo a physical examination, medical history and nutritional status review, fetal heart rate measurement, blood collection, an ultrasound, an adherence questionnaire, and a nose and throat swab procedure. They will then receive their assigned vaccine. Participants will not be told which vaccine they are receiving. Participants will remain in the clinic for 30 to 60 minutes after receiving the vaccine for monitoring. They will attend study visits 14 to 21 days after the vaccination visit, at Week 8, and at the time of labor and delivery. During these visits, they will undergo select baseline study procedures. After delivery, participants' babies will have a physical examination and blood collection. At 2 and 4 months after delivery, participants' babies will undergo select baseline study procedures. Participants' babies will receive the PCV vaccine according to the local standard of care.
Step 2 of the study will begin 6 months after delivery, at which time participants and their babies will attend a study visit for a physical examination, medical history and nutritional status review, an adherence questionnaire, and blood collection. Participants who received the PPV-23 vaccine or the PCV-13 vaccine in Step 1 will end their participation in the study after this visit. Participants who received placebo vaccine in Step 1 will be randomly assigned to receive the PPV-23 vaccine or PCV-13 vaccine at this study visit but will not be told which vaccine they are receiving. Participants will attend a study visit 14 to 21 days after receiving the vaccine, which will include select study procedures.
- Conditions
- Pneumococcal Infections, HIV Infections
- Being tested
- PPV-23 Vaccine, PCV-13 Vaccine, Placebo Vaccine
- Medical subject headings
- Pneumococcal Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV-23 VaccineBiological
Administered as a 0.5 mL IM dose
PCV-13 VaccineBiological
Administered as a 0.5 mL IM dose
Placebo VaccineBiological
Administered as a 0.5 mL IM dose
| Study group | Role | What they receive |
|---|---|---|
| Step 1: PPV-23 Vaccine (Arm 1a) | Experimental | Participants will receive one intramuscular (IM) injection of 0.5 mL of the PPV-23 vaccine at baseline. Receives: Biological: PPV-23 Vaccine |
| Step 1: PCV-13 Vaccine (Arm 1b) | Experimental | Participants will receive one IM injection of 0.5 mL of the PCV-13 vaccine at baseline. Receives: Biological: PCV-13 Vaccine |
| Step 1: Placebo Vaccine (Arm 1c) | Placebo comparator | Participants will receive one IM injection of 0.5 mL of the placebo vaccine at baseline. Receives: Biological: Placebo Vaccine |
| Step 2: PPV-23 Vaccine (Arm 2a) | Experimental | Participants will receive one IM injection of 0.5 mL of the PPV-23 vaccine 6 months after delivery. Receives: Biological: PPV-23 Vaccine |
| Step 2: PCV-13 Vaccine (Arm 2b) | Experimental | Participants will receive one IM injection of 0.5 mL of the PCV-13 vaccine 6 months after delivery. Receives: Biological: PCV-13 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
For women: Grade 3 or higher adverse events
Measured: 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: 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: 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: Measured at 8 weeks of age for infants
For women: Pneumonia or invasive pneumococcal disease
Measured: Measured through approximately 60 weeks
For women: Grade 3 or higher pregnancy-specific systemic adverse events
Measured: Measured through approximately 60 weeks
For women: Significant changes in HIV viral load in pregnant participants
Measured: Measured through approximately 60 weeks
For infants: Congenital defects
Measured: Measured through approximately 36 weeks
For infants: Pneumonia or invasive pneumococcal disease
Measured: Measured through approximately 36 weeks
For infants: In-utero or perinatal HIV infection
Measured: Measured through approximately 36 weeks
For infants: Immune interference with infant response to PCV vaccine
Measured: Measured through approximately 36 weeks
Secondary outcomes (2)
Infant maternal antibodies at 2 months of life
Measured: Measured at 2 months of age for infants
Maternal and infant vitamin D levels
Measured: Measured through approximately 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adriana Weinberg, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443117
- Sponsor's protocol ID
- P1091
- Other IDs
- 11687
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2011
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18382741Lopez-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.
PubMed 14981752
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
- 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
- ClinicalTrials.gov ID
- NCT01443117
- Acronym / sponsor ID
- P1091
- Conditions
- Pneumococcal Infections, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Aug 2014 (estimated)
- First posted
- 29 Sep 2011 (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.
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.
Detailed description
Pneumococcus is the most common bacterial opportunistic infection in HIV-infected children, and it is the leading cause of bacterial pneumonias in HIV-infected pregnant and non-pregnant adults. Pneumococcal polysaccharide vaccine (PPV-23) and pneumococcal conjugate vaccine (PCV-13) are two vaccines used for the prevention of pneumococcal (PNC) disease. The PPV-23 vaccine is recommended by the Centers for Disease Control and Prevention (CDC) for HIV-infected adults, including HIV-infected pregnant women. The PCV-13 vaccine is recommended by the CDC for use in children, including HIV-infected children. Studies have shown that PCV-13 and vaccines like PCV-13 are safe for use in healthy pregnant women, but they have not been studied in HIV-infected pregnant women. This study will compare the safety and immune response to the PCV-13 and PPV-23 vaccines in HIV-infected pregnant women.
This study will enroll HIV-infected pregnant women in their second or third trimester who are receiving antiretroviral therapy. The study will take place in two steps. In Step 1, participants will be randomly assigned to receive PPV-23 vaccine, PCV-13 vaccine, or placebo vaccine. At a baseline study visit, participants will undergo a physical examination, medical history and nutritional status review, fetal heart rate measurement, blood collection, an ultrasound, an adherence questionnaire, and a nose and throat swab procedure. They will then receive their assigned vaccine. Participants will not be told which vaccine they are receiving. Participants will remain in the clinic for 30 to 60 minutes after receiving the vaccine for monitoring. They will attend study visits 14 to 21 days after the vaccination visit, at Week 8, and at the time of labor and delivery. During these visits, they will undergo select baseline study procedures. After delivery, participants' babies will have a physical examination and blood collection. At 2 and 4 months after delivery, participants' babies will undergo select baseline study procedures. Participants' babies will receive the PCV vaccine according to the local standard of care.
Step 2 of the study will begin 6 months after delivery, at which time participants and their babies will attend a study visit for a physical examination, medical history and nutritional status review, an adherence questionnaire, and blood collection. Participants who received the PPV-23 vaccine or the PCV-13 vaccine in Step 1 will end their participation in the study after this visit. Participants who received placebo vaccine in Step 1 will be randomly assigned to receive the PPV-23 vaccine or PCV-13 vaccine at this study visit but will not be told which vaccine they are receiving. Participants will attend a study visit 14 to 21 days after receiving the vaccine, which will include select study procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Step 1: PPV-23 Vaccine (Arm 1a) | Experimental | Biological: PPV-23 VaccineParticipants will receive one intramuscular (IM) injection of 0.5 mL of the PPV-23 vaccine at baseline. |
| Step 1: PCV-13 Vaccine (Arm 1b) | Experimental | Biological: PCV-13 VaccineParticipants will receive one IM injection of 0.5 mL of the PCV-13 vaccine at baseline. |
| Step 1: Placebo Vaccine (Arm 1c) | Placebo comparator | Biological: Placebo VaccineParticipants will receive one IM injection of 0.5 mL of the placebo vaccine at baseline. |
| Step 2: PPV-23 Vaccine (Arm 2a) | Experimental | Biological: PPV-23 VaccineParticipants 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) | Experimental | Biological: PCV-13 VaccineParticipants will receive one IM injection of 0.5 mL of the PCV-13 vaccine 6 months after delivery. |
Who may qualify
- Ages
- 13 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (30 listed)
- 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
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 |
|---|---|---|
| PPV-23 VaccineAdministered as a 0.5 mL IM dose | Biological | Step 1: PPV-23 Vaccine (Arm 1a), Step 2: PPV-23 Vaccine (Arm 2a) |
| PCV-13 VaccineAdministered as a 0.5 mL IM dose | Biological | Step 1: PCV-13 Vaccine (Arm 1b), Step 2: PCV-13 Vaccine (Arm 2b) |
| Placebo VaccineAdministered as a 0.5 mL IM dose | Biological | Step 1: Placebo Vaccine (Arm 1c) |
Primary outcome
For women: Grade 3 or higher adverse events
Time frame: Measured through approximately 60 weeks
For women: Grade 3 or higher adverse events judged to be at least possibly related to the study treatment
Time frame: Measured through approximately 60 weeks
For women: A 2-fold increase in ELISA or 4-fold rise in opsonic activity (OPA)-measured antibody concentrations
Time frame: Measured at 14 to 21 days after immunization
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.
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
Time frame: Measured at 8 weeks of age for infants
Reaching this level of antibodies for 3 of the 4 PNC serotypes that will be tested defines success
For women: Pneumonia or invasive pneumococcal disease
Time frame: Measured through approximately 60 weeks
For women: Grade 3 or higher pregnancy-specific systemic adverse events
Time frame: Measured through approximately 60 weeks
For women: Significant changes in HIV viral load in pregnant participants
Time frame: Measured through approximately 60 weeks
For infants: Congenital defects
Time frame: Measured through approximately 36 weeks
For infants: Pneumonia or invasive pneumococcal disease
Time frame: Measured through approximately 36 weeks
For infants: In-utero or perinatal HIV infection
Time frame: Measured through approximately 36 weeks
For infants: Immune interference with infant response to PCV vaccine
Time frame: Measured through approximately 36 weeks
2 secondary outcomes
Infant maternal antibodies at 2 months of life
Time frame: Measured at 2 months of age for infants
Maternal and infant vitamin D levels
Time frame: Measured through approximately 60 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 18382741Scott 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.
- Background: PubMed 14981752Lopez-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.
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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.
Adriana Weinberg, MD study chair
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPV-23 Vaccine and PCV-13 Vaccine in people with Pneumococcal Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 10 inclusion and 30 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: withdrawn, 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
For women: Grade 3 or higher adverse events (time frame: Measured through approximately 60 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443117, which also lists 2 linked publications.
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.