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HIV Vaccine Research Update and NIAID HIV Vaccine Research Education Initiative (NHVREI). National ADAP TA Meeting Murray Penner and Natalie Cramer July 10, 2008. NASTAD NHVREI Activities. NASTAD’s involvement in HIV vaccine education Overview of HIV vaccine development

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national adap ta meeting murray penner and natalie cramer july 10 2008
HIV Vaccine Research Update and

NIAID HIV Vaccine Research Education Initiative (NHVREI)

National ADAP TA MeetingMurray Penner and Natalie Cramer July 10, 2008

nastad nhvrei activities
NASTAD NHVREI Activities
  • NASTAD’s involvement in HIV vaccine education
  • Overview of HIV vaccine development
  • Overview of the NASTAD NHVREI activities
time between discovery of infectious agents and development of vaccines
Time between discovery of infectious agents and development of vaccines

Source: Modified from H. Markel, NEJM, August 25, 2005

slide5
Vaccine research and development

VACCINE DESIGN

PRECLINICAL RESEARCH

CLINICAL TRIALS

DISCOVERY

timeline for efficacy data from current and planned vaccine trials 2007
Timeline for Efficacy Data From Current and Planned Vaccine Trials, 2007

2004

2005

2006

2007

2008

2009

2010

2011

2012

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

*

RV 144

*

HVTN 502

HVTN 503

*

PAVE 100

*

RV 144

HVTN 502

HVTN 503

PAVE 100

*

Anticipated Data Availability

timeline for efficacy data from current and planned vaccine trials
Timeline for Efficacy Data From Current and Planned Vaccine Trials

2004

2005

2006

2007

2008

2009

2010

2011

2012

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

*

RV 144

STOPPED

HVTN 502

STOPPED

HVTN 503

PAVE 100

Under Construction

?

RV 144

PAVE 100

*

Anticipated Data Availability

phase iii trial in thailand rv144 with dod thailand moph hjf sanofi vaxgen
Phase III Trial in Thailand (RV144) (with DoD, Thailand MOPH, HJF, Sanofi, VaxGen)
  • Canarypox + gp120 envelope protein boost
  • Completed immunization phase July 06
    • N=16,000 volunteers
    • Now in follow-up phase
  • Continued DSMB oversight
  • Final results anticipated in 2009
step and phambili
STEP and Phambili
  • Suspended enrollment and study injections
  • Unblinded participants (Phambili, then STEP)
  • Counseled participants about possible increased risk of HIV infection
  • Continued follow up in both trials to assess vaccine effects
summary of recent trials
Summary of Recent Trials
  • Study design and execution provided earliest possible answer
  • Vaccine failed, not the trial
  • Animal models did not predict outcome in humans
  • More infections among vaccinees vs. placebo recipients
    • Why?  chance? due to vaccine? some other cause?
    • Increased risk of HIV infection among vaccinees most evident in uncircumcised men with pre-existing Ad5 immunity
    • No evidence of increased risk among vaccinees in circumcised men without pre-existing Ad5 immunity
    • Further studies underway to provide clues as to possible biological mechanisms
current pave 100 protocol under consideration
Current PAVE 100 Protocol Under Consideration
  • PAVE 100A
    • U.S. only
    • Circumcised, Ad5 seronegative MSM
  • Primary endpoints
    • Safety
    • HIV viral load post-infection
  • Secondary and exploratory
information cycle iterative process forward
Information CycleIterative Process Forward

Preclinical Research & Development

Discovery

Clinical Research

nastad nhvrei activities year one
NASTAD NHVREI Activities (Year One)

Provide an overview of HIV vaccine research and clinical trials in NASTAD Prevention Bulletin (March 2008).

Conduct a special session during NASTAD Annual Meeting focusing on HIV vaccine research and clinical trials (May 2008).

Highlight and promote HIV Vaccine Awareness Day (May 2008).

nastad nhvrei activities year one continued
NASTAD NHVREI Activities (Year One) - continued

Conduct a breakout session at National ADAP TA Meeting focusing on HIV vaccine research and clinical trials (July 2008).

Conduct a brown-bag educational lunch for NASTAD staff focusing on HIV vaccine research and clinical trials (Summer 2008).

Conduct a breakout session at National Viral Hepatitis TA Meeting focusing on HIV vaccine research and clinical trials (September 2008).

nastad nhvrei activities year one continued1
NASTAD NHVREI Activities (Year One) - continued

Produce fact sheet for HDs designed to increase awareness of HIV vaccine research and clinical trials; highlight HD best practices (Fall 2008).

Conduct a national TA conference call for HD staff to increase awareness and education of vaccine research and clinical trials (Fall 2008).

Routinely distribute information regarding HIV vaccine research and clinical trials in existing publications (ongoing).

nastad nhvrei activities year one continued2
NASTAD NHVREI Activities (Year One) - continued

Identify and participate in at least one conference (to be determined) and highlight HD efforts to increase awareness of HIV vaccine research and clinical trial participation (February 28, 2009).

nastad nhvrei year two and ongoing activities
NASTAD NHVREI (Year Two) andOngoing Activities

Year Two

Continue all activities from Year One.

Conduct a national webinar on HIV Vaccine Awareness Day (May 2009).

Ongoing Activities

Program Reporting

Evaluation activities

Ongoing Training and TA for Project Staff

slide20
HIV Vaccine Research Contact Information

For more detailed information about HIV vaccine research,

please view the following websites:

www.bethegeneration.org

www.niaid.nih.gov/daids/vaccine

www.hvtn.org

www3.niaid.nih.gov/about/organization/vrc

…or contact

NIAID’s HIV Vaccine Trials Network at www.hvtn.org

or AIDS Info at 1-800-448-0440

Para más información en el Español acerca de vacunas de SIDA,

LLAME: 1-800-448-0440 (marque el número 2)

nastad contact information
NASTAD Contact Information

Murray C. Penner

Deputy Executive Director, Domestic Programs

[email protected]

Natalie O. Cramer

Senior Manager, Prevention

[email protected]

Joy Mbajah

Manager, Prevention (and NHVREI Project Manager)

[email protected]

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