Trials Sponsors Conditions Drugs Pricing

Conditions

H1N1 Influenza Virus HIV Infections

Keywords

VaccinePregnantPerinatal

Outcome Measures

Primary Outcomes (4)

The Number of Participants Who Had at Least One Adverse Event (AE)
Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Measured up to 6 months after delivery
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Measured up to 6 months after delivery
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Measured at Day 21

Secondary Outcomes (6)

Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery
Measured at delivery of the baby, and at 3 months and 6 months after delivery
Percent of Infants With an HAI Titer of >= 40
Measured at birth (via cord blood) and at 3 months and 6 months of age
Maternal Geometric Mean Titers (GMT) of Antibodies HAI
Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery
Infant GMT of Antibodies HAI
Measured at birth and at 3 and 6 months of age
Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values
Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose
+1 more secondary outcomes

Study Arms (1)

H1N1 vaccine

EXPERIMENTAL

Pregnant women enrolled received two doses of H1N1 vaccine, administered 21 days apart.

Biological: Influenza A (H1N1) monovalent vaccine

Interventions

Influenza A (H1N1) monovalent vaccineBiological

Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart

H1N1 vaccine

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 39 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Confirmed diagnosis of HIV-1 infection
Pregnant

Sponsors & Collaborators

Study Sites (31)

Usc La Nichd Crs

Alhambra, California, 91803, United States

University of California, UC San Diego CRS

La Jolla, California, 92093-0672, United States

Miller Children's Hosp. Long Beach CA NICHD CRS

Long Beach, California, 90806, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, 90095-1752, United States

Univ. of California San Francisco NICHD CRS

San Francisco, California, 94143, United States

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 80045, United States

Washington Hosp. Ctr. NICHD CRS

Related Publications (5)

Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
PMID: 19423869BACKGROUND
Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, Lindstrom S, Louie JK, Christ CM, Bohm SR, Fonseca VP, Ritger KA, Kuhles DJ, Eggers P, Bruce H, Davidson HA, Lutterloh E, Harris ML, Burke C, Cocoros N, Finelli L, MacFarlane KF, Shu B, Olsen SJ; Novel Influenza A (H1N1) Pregnancy Working Group. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet. 2009 Aug 8;374(9688):451-8. doi: 10.1016/S0140-6736(09)61304-0. Epub 2009 Jul 28.
PMID: 19643469

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)

Study Officials

Sharon Nachman, MD
State University of New York at Stony Brook
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

130 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Has a known allergy to eggs, egg products, neomycin, or polymyxin
Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV
Participation in a novel H1N1 influenza vaccine study in the past 2 years
Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel influenza H1N1 infection or positive influenza diagnostic test since June 2009 (specificity to H1N1 not required) prior to study entry
Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry
Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study or expects to receive another nonlicensed agent before delivery
Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry
Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus \[HPV\]-related cervical dysplasia, and cervical intraepithelial neoplasia \[CIN\] Grades 1, 2, or 3)
Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months. Nasal and topical steroids are allowed.
Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to enrollment in this study
Current diagnosis of uncontrolled major psychiatric disorder
History of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children)
Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes (DTRs) in both legs (all four absent) within the past 6 months
Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) within the past 6 months
+15 more criteria

Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (6)

Study Arms (1)

H1N1 vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (6)

Study Arms (1)

H1N1 vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations