Afri-Can Synchronicity Forum Laico Lake Victoria Hotel Entebbe, Uganda 17 _ 19 Jan 2013 OVERVIEW: Creating A Common Platform for HIV Vaccine Research and.

Afri-Can Synchronicity ForumLaico Lake Victoria Hotel Entebbe, Uganda 17_19 Jan 2013

OVERVIEW: Creating A Common Platform for HIV Vaccine Research and HIV Care and Treatment

Program: Nigerian Canadian Collaboration On AIDS Vaccine (NICCAV) Study

PI: Alash’le G Abimiku, M.Sc; PhD

Institute of Human Virology, Nigeria

University of Maryland School of Medicine

Co PI: Dr. Gary Gaber, MD

University of Ottawa, Ottawa Hospital

Funding: Canadian Global Health Research Initiative

GHRI/CIDA/IDRC/CIHR

1.8

3.8

4.5

5.4

5.8

5.0

4.44.6

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

1991 1993 1995/96 1999 2001 2003 2005 2008

Year

Pre

vale

nce (

%)

1991 ’93 ’95 ’99 ‘2001 ’03 ’05 ‘08

1.8

3.8

4.5

5.85.4

4.4 4.65.0

• Capital City: Abuja• Population: 170,123,740 (2012 est)• GDP - per capita (PPP): $2,578 (2011 est.) • Land Area 910,770 sq km (351,648 sq miles) (slightly more than 2ce the size of California

Background on NigeriaHIV Seroprevalence

• PLWH-2.95m (♂-1.23m, ♀-1.72m) • Cumulative AIDS Death- 2.99m

(♂-1.38m, ♀-1.61m)• Total AIDS orphaned- 2.23million • New infection- 380, 000 (Adult-

323,000, Children- 57,000)• 2nd ranked globally for HIV burden• 4th ranked for TB burden globally

GHRI/CIDA/IDRC/CIHR

IHV-Nigeria StructureIHV - NigeriaIHV -

Research TrainingTreatment and

Care

CDC Acute HIV Infection

APIN - Gates Foundation

PMTCT

NIH Fogarty

NIH - IHV Nigeria AR

CDC UTAP

AIDS Care and Treatment in Nigeria

NeuroAIDS

TB - HIV

Doris Duke CDC

Adherence

CDC PEPFAR

PHE

GCC HIV Malignancy

Clinical Trial Unit

NIH AVERT

CDCPeds

GFATMHSS,Malaria

HIV, TBCollaborate with:• 8 major Universities• 20 National Specialist Hospitals & Federal Medical Centers

NigeriaIHVN

GHRI/CIDA/IDRC/CIHR

CHRI (NICCAV)

CDC Pre- and In- Servie Training

NIH H3Africa

PEPFAR Laboratory Capacity Building

Plateau State Human Virology Research Center (PLASVIREC), JosPCR, Cell Culture, Serology, PBMCs storage & flow cytometry

Asokoro Lab Training Center (ALTC), AbujaPCR and Sequencing

National TB and Leprosy Training Center (NTBLTC) Zaria; TB culture & molecular assays

GHRI/CIDA/IDRC/CIHR

NICCAV Study Rationale

.

GHRI/CIDA/IDRC/CIHR

1. Despite a national seroprevalence of 4.1%, Nigeria has the 2nd highest burden of HIV in the world. Additionally being the most populous nation in Africa, it has the highest number persons that would require an effective HIV vaccine, yet not a single HIV vaccine trial has occurred in Nigeria or any part of W. Africa.

2. Access to Highly Active Antiretroviral Therapy (HAART) through large programs like the US PEPFAR has significantly enhanced infrastructural capacity and life quality and expectancy

3. However, an effective HIV vaccine (s) remains the best hope of ending the epidemic

4. National HIV vaccine plan developed since 2001 and has been recently updated with plans for NACA coordinated implementation by partners, institutions and NGOs.

NICCAV Study RationaleGHRI/CIDA/IDRC/CIHR

6. A unique HIV subtype G, CRF02 A/G epidemic that accounts for about 40% of the population at the epicenter of the HIV pandemic

Subtype G

CRF06_cpxCRF02_AG

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11

Per

cen

t Ib

NG

Sen

egal

West African Country

Gui

nea

Bis

sau

Cot

e D

’Ivo

ire

Gh

ana

Mal

i

Tog

o

Ben

in

Nig

eria

Nig

er

Cam

eroo

n

Gab

on

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11

Per

cen

t Ib

NG

Sen

egal

West African Country

Gui

nea

Bis

sau

Cot

e D

’Ivo

ire

Gh

ana

Mal

i

Tog

o

Ben

in

Nig

eria

Nig

er

Cam

eroo

n

Gab

on

Common HIV-1 subtypes in:

Nigeria West Africa

Study GoalGHRI/CIDA/IDRC/CIHR

NICCAV study goal is to create an internationally certified HIV clinical research site capable of conducting HIV vaccine clinical trials in populations with defined risk of HIV infection using the highest international scientific standard and utilizing the infrastructure developed through PEPFAR

University of Ottawa, Canada• Training in HIV vaccine clinical trials capacity • Training in regulatory oversight

Institute of Human Virology, University of Maryland SOM

• IHV-UMD Fogarty Training in Nigeria on Epidemiological research tools

Objective 1. Training in HIV Vaccine Ethics and Regulation

Training of leadership from:National Agency for AIDS Control (NACA) • Coordination of National strategic plan and AIDS Vaccine Plan

National Agency for Food and Drug Administration and Control (NAFDAC)• Approval of protocols for HIV vaccine candidates and oversight

National Health Research Ethical Committee (NHREC)• Clinical trial protocol approval• Clinical trail monitoring

1) Discordant couples cohort Counseling Unit Plateau State Human Virology Research Center (PLASVIREC)

2) Community Participation (NHVMAS) Community mobilization and education campaign linked to cohort development

Objective 2. Cohort development and Community Involvement

Institute of Human

Virology-Nigeria• Administration of grant

• Study protocol implementation

• Overall oversight

Central Implementing body

Objective 3. Building laboratory capacity to support HIV vaccine Trials

Develop one research laboratories at study site to be fully GCLP compliant

Building clinical, Regulatory and Community capacityGHRI/CIDA/

IDRC/CIHR

TrainingsGHRI/CIDA/IDRC/CIHR

• Didactic trainings at the Institute of Human Virology (linking with

University of Maryland NIH Fogarty program (PI: Blattner)• Epidemiology and Research Ethics (also web based

http://www.ihvnigeria.org/ihvnweb)• Statistical Methods in Epidemiology • Research Ethics and Regulatory Affairs http

://www.westafricanbioethics.net/wabcms

https://www.citiprogram.org. • Community engagement and education on HIV vaccine trials• Community engagement by the New HIV Vaccine and

Microbicide Advocacy Society (NHVMAS) using the Good

Participatory Practice Guidelines (led by Dr. Morenike Ukpong)

Objective 1Training of Regulatory Bodies

Trainings Trainees RemarksStatistical Methods and Epidemiology

8 persons involving NACA, NAFDAC, NHREC and research team

IHVN led training

Research Ethics training

12 persons involving NHREC and the research team

IHVN led training. ALL are GCLP compliant

Introductory course on Clinical trials

5 persons among the research team

IHVN led training

Regulatory & monitoring of Clinical Trials

3 persons from NAFDAC and IHVN

Ottawa led training: 2 persons were denied visas

GHRI/CIDA/IDRC/CIHR

Training of Study team

Msc Clinical trials at the University of Maryland Baltimore

North to South training since Sept last year

On site laboratory training at CDC ISO accredited lab Kemri, Kenya

1 South to South, Successfully completed and implementing ongoing

M & E course at the University of Pretoria, S.Africa

South to South. Successfully completed

GHRI/CIDA/IDRC/CIHR

Objective 2:Cohort CharacteristicsGHRI/CHVI/

CIDA/IDRC/CIHR

• 545 Seronegatives enrolled (target is 500)

• Similar numbers of both genders enrolled

• 94% retention during up to 9 months follow up

• 26% never use condoms: 34% inconsistent use

• Up to 94.3% of HIV+ partners are on HAART through PEPFAR

• Despite that 25% have viral load of 10,000 to 1.6m

• 75% have detectable virus load but <10,000 copies

• Incidence of 0.6% have been recorded in the cohort during

this 9 months follow up

• 34% of the seronegative had hypertension; and 15% had

anemia.

Community Engagement

• 16 Civil Society Organization formed

• 10 member CAB members with monthly trainings on research literacy

• 10983 person (6091 males, 4892 females) has been informed about NICCAV and HIV vaccines research literacy

• Two successful media round table discussion published in some newspapers e.g.

GHRI/CIDA/IDRC/CIHR

Led by NHVMAS, Dr. Ukpong (a sub grantee)

WHO-AFRO Guidance for SLIPTA Implementation

SLIPTA Guidelines finalized during the consultative meeting held in Nairobi, Kenya in July 2011.

Established to institute a Laboratory quality improvement process & implementation in a stepwise manner

Framework for countries to improve national laboratory services towards ISO 15189 standard

Country owned program

GHRI/CIDA/IDRC/CIHR

Scoring and Star Levels

Stepwise Process

1 Star

5 Star

2 Star

3 Star

4 Star

65-74 %

75-84 %

85-94 %

≥ 95 %

Scores (%)0 Star

End Point

Link to Accreditation Body

55-64 %

Certificate of Recognition

Laboratory Accreditation

• PLASVIREC has improved from 2 star to 4 star (the highest score being 5) on the WHO-AFRO

• On site laboratory training at CDC ISO accredited lab Kemri, Kenya of Plasvirec Laboratory Manager

• PLASVIREC currently carrying out the process for ISO 15189 Accreditation

GHRI/CIDA/IDRC/CIHR

Plateau State Human Virology Research Center (PLASVIREC)

PLASVIREC

Conclusions1. The sero-discordant cohort is still relevant for vaccine studies due the

potential for HIV transmission from HIV+ partners with moderate to high viral load despite being on HAART. There is also low condom use; and the presence of STIs.

2. This cohort of exposed person in a normal relationship (as opposed to highly exposed cohorts) is a viable cohort for testing responses to vaccines in an exposed population who may be participating in vaccine trials as “normal” seronegative controls

3. National bodies and the local community are critical for awareness and support for HIV vaccines.

4. Continuous mentoring is required to have effective bodies to review very complex HIV vaccine protocols and monitor these trials

5. Laboratory accreditation of research facility has significantly upgrade the standards of processes at site to ensure high quality samples

GHRI/CIDA/IDRC/CIHR

Strategic Future Needs

• Support for Manuscript and grant writing to capture the success of this funding

• Sustainable mentoring of regulatory bodies and trained personnel is essential

• Clinical trials (HIV vaccine Phase I/II or other related trails) is needed to utilize the well characterized cohort; trained research staff; supportive ethical and regulatory bodies, and community; and an accredited laboratory at our site.

GHRI/CIDA/IDRC/CIHR

Acknowledgement

• Study participants • Dr. Morenike Upkpong, community leaders and the

Community • PLASVIREC, Jos Research team• Ottawa and Nigeria leadership and investigators• Nigerian National Agencies leadership (Prof. Idoko

(NACA), Dr. Orhii (NAFDAC); Mr. Yakubu (NHREC)• Sponsors: GHRI, CIHR, CHVI, CIDA, IDRC

GHRI/CHVI/CIDA/IDRC/CIHR