Clinical Research in Pregnant Women – Knowledge, Gaps and Opportunities
Sponsored by NIH and BMGF
Fischer’s Lane Conference Center, Bethesda, MD,
September 29th and 30th, 2014
Advance registration required, space is limited!
To register, email Dr. Mirjana Nesin, nesinm@niaid.nih.gov by September 18th
Conference Objectives:
Identify key knowledge gaps, opportunities and barriers to research during pregnancy in the context
of global health, vaccines and antimicrobials.
Develop research tools to assist design and implementation of clinical trials of vaccines and
antimicrobials during pregnancy with an emphasis on research in low resource settings.
Organizational Committee: Ajoke Sobanjo-ter Meulen (BMGF), Anne Zajicek (NICHD), Tonse Raju
(NICHD), Marion Koso-Thomas (NICHD), Maggie Brewinski Isaacs (ORWH), Jennifer Read (NIAID/DAIT),
Olivia Sparer (NIAID/DMID), and Mirjana Nesin (NIAID/DMID).
Draft Agenda
September 29th, 2014
8am-8:30 am: Registration
8:30-8:40 am: Welcome Remarks, Dr. Richard Gorman, Associate Director of Clinical Research, DMID
Presentations are 15 minutes each followed by 5 minutes discussion
8:40 – 10:20 am Introduction – Overview of issues related to enrollment of pregnant women in clinical
trials Moderators (TBD), Richard Beigi
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Influenza H1N1 vaccination and adverse pregnancy outcome: a population based cohort study in
Stockholm, Sweden, Bergman Ulf, Stockholm, Sweden
Pregnancy complications: prevalence and reporting in low resource settings, Sonali Kochhar, JSI,
New Delhi, India
Effects of changing natural history and participation in the study on pregnancy and study
outcome, Dr. Miriam Laufer, University of Maryland, Baltimore, MD
Overview of BMGF maternal immunization initiative, Ajoke Sobanjo-ter Meulen, BMGF
Review of PATH’s efforts on maternal immunization, Dr. Kathy Neuzil, PATH
Session Summary
Break 10:20-10:30 am
Clinical Research in Pregnant Women – September 29-30, 2014
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10:30 am - 1:30 pm Session I: Clinical Research During Pregnancy in Low Resource Settings,
moderated by Ajoke Sobanjo-ter Meulen, BMGF, and Marion Koso-Thomas, NICHD
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Enrolling pregnant women in clinical trials in low resource settings: barriers and opportunities,
Dr. Shabir Madhi, Johannesburg, South Africa
Design of clinical trials enrolling pregnant women in low resource settings, Dr. Omrana Pasha,
Aga Khan University Karachi, Pakistan
Endpoints and outcome measures in clinical trials of maternal immunization in international
settings, Dr. Saad Omer, Emory University
Designing natural history studies to precede clinical trials:
o RSV surveillance study in Argentina, Fernando Polack, Argentina/USA
o GBS surveillance study in Kenya, Jay Berkley, UK
Developing international research sites: from a prospective of local investigators, Dr. Romano
Nkumbwa Byaruhanga, Kampala, Uganda
Experiences from Novartis GBS trial: Implementation of clinical trials enrolling pregnant women
in low resource settings: from a prospective of local investigators, Dr. Clare Cutland, National
Institute for Communicable Diseases, South Africa
Assessing and reporting adverse events in pregnancy studies in South Asia, Dr. Mark Steinhoff,
Cincinnati Children’s Hospital, Ohio
Experience from flu and meningococcal maternal immunization trial in Mali, Dr. Mili Tapia,
University of Maryland, Baltimore, MD
Overcoming barriers to conducting clinical research during political turmoil, Dr. Samba Sow, Mali
1:30- 2:00 pm: LUNCH
2:00 – 4:00 pm Session II: Morbidities and Pregnancy moderated by Dr. Maggie Brewinski Isaacs,
NIH/ORWH and Greg Deye, NIAID/DMID
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Preventive and treatment related research during pregnancy, Dr. Clayton, Director of OWHR, or
Dr. Maggie Brewinski Isaacs
Pregnancy and infection, Dr. Jennifer Read (NIAID/DAIT)
‘Treating for two’ with emphasis on infection treatment during pregnancy, Dr. Cheryl Broussard,
CDC
Could we use tox tables like NCI, DAIDS, or need to develop specific tables for women with comorbidities: DAIDS experience? Jeanna Piper, DAIDS
Including obese pregnant women in vaccine studies: why, who, and how, Dr. Lisa Christian,
Columbus, Ohio,
Session summary
4:00 - 4:10 pm Break
4:10 – 5:00 pm - Round table discussion moderated by Ajoke Sobanjo-ter Meulen, BMGF, and Marion
Koso-Thomas, NICHD
What do investigators implementing studies in low resource settings need from sponsors, regulators,
ethics committees to safely and effectively conduct research in low resource settings?
6 pm
RECEPTION
Clinical Research in Pregnant Women – September 29-30, 2014
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September 30th, 2014
8:00-8:30 am Registration
8:30 -10:10 am Session III: Regulatory Science and Ethics: moderated by Dr. Anne Zajicek, NICHD, and
Jeff Roberts, FDA/CBER
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How can innovation in regulatory science inform the regulatory process to facilitate
development of new vaccines to be used in pregnancy? Jeff Roberts, FDA/CBER
Importance and the challenges of developing a CMV vaccine (or other preventative
interventions) to protect pregnant women and their offspring from CMV infection and its
consequences, Tong-Ming Fu, Merck
Definitions for adverse events reporting following immunizations during pregnancy, Philipp
Lambach, WHO, Geneva, Switzerland
Benefits and limitations of pregnancy registries, Melissa Tassinari, FDA/CDER
Ethical and practical issues (consents, IRBs) related to enrolling pregnant women in research,
Amina White NIH/Ethics Department
Session Summary
10:10- 10:20 am Break
10:20 am – 12:00 pm Session IV: Effect of maternal immunization and treatment on neonatal outcomes,
moderated by Dr. Janet Englund, Seattle Children’s Hospital, and Jennifer Read, (NIAID/DAIT)
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Assessing impact of maternal immunization on infant immunity, Dr. Janet Englund, Seattle
Children’s Hospital
Maternal Pertussis immunization: Lessons learned and new questions to be addressed, Dr. Kathy
Edwards, Vanderbilt, Nashville, Tennessee
Effect of maternal immunization with pertussis during pregnancy on infant’s immune response:
Flor Munoz, Baylor, TX
RSV: cons and pros to maternal immunization during pregnancy and infant passive:
o Novavax maternal immunization program, Greg Glenn, NovaVax,
o Infant immunization, Pamela Griffith, MedImmune
Session Summary
12-12:15pm: Closing Remarks: Richard Gorman or Mirjana Nesin
12 – 1pm – LUNCH
1:00 – 3:00 pm Working Group Sessions (working groups will meet in parallel)
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Working Group 1: Reporting birth defects : training tool for investigators, moderator TBD
Working Group 2**: Developing eCRFs in CDISC for studies during pregnancy, moderated
by Jennifer Ferreira, EMMES Corporation, Rockville, Maryland
Working Group 3: Developing web-based based resources for investigators implementing
clinical research of antimicrobials and vaccines during pregnancy, moderated by Shital
Patel, Baylor, Huston, Texas
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** Working Group 2 is tasked with developing eCRFs for vaccine studies enrolling pregnant women that
would be CDISC conformant. Rationale is that CDICS conformant forms are already being used in DMID
sponsored studies in healthy adults. Expanding forms/tables and terminology to include more detailed
information about pregnant participants and their infants would be very useful for studies enrolling
pregnant women and also, if a subject enrolled in other types of trials becomes pregnant. The resulting
forms will also be shared with CDISC Vaccines group for consideration in their development of standards
and controlled terminology for domains specific to pregnant subjects.
Agenda for ‘CDISC Working Group’ session on September 30th, 2014:
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Participants’ introductions (5-10 minutes) (please specifically mention interest and expertise
relevant to objectives of this working group)
2.
Brief description of CDISC and WG’s objectives (10 minutes): Jennifer Ferreira, EMMES
WG objective: review and revise draft Maternal History, Pregnancy Outcome and Neonatal
Outcome forms (provided by EMMES) to become potentially CDISC conformant
3. Discussion and revisions of the forms: entire WG
4. Summary and steps forward: finalization of the documents via teleconferences, Jennifer
Ferreira, The EMMES Corporation.
At the meeting, EMMES (DMID Data Management Center) will provide forms as a starting point for
discussion.
3pm: Adjourn
Clinical Research in Pregnant Women – September 29-30, 2014
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