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Cablegate: Clinical Trials for Human Avian Influenza Vaccine Begin In

VZCZCXRO0409
OO RUEHCHI RUEHCN RUEHDT RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD
DE RUEHHI #0599/01 1430350
ZNR UUUUU ZZH
O 220350Z MAY 08
FM AMEMBASSY HANOI
TO RUEHC/SECSTATE WASHDC 7865
INFO RUEAUSA/DEPT OF HHS WASHINGTON DC IMMEDIATE
RUEHHM/AMCONSUL HO CHI MINH 4748
RUEHZS/ASEAN REGIONAL FORUM COLLECTIVE
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUEHUL/AMEMBASSY SEOUL 3334
RUEHKO/AMEMBASSY TOKYO 5880
RUEHHK/AMCONSUL HONG KONG 1447
RUEHGZ/AMCONSUL GUANGZHOU 0899
RUEHCN/AMCONSUL CHENGDU 0362
RUEHIN/AIT TAIPEI 1604
RUEAIIA/CIA WASHINGTON DC
RUEHPH/CDC ATLANTA GA
RUEHRC/DEPT OF AGRICULTURE WASHINGTON DC
RUEKJCS/SECDEF WASHINGTON DC//USDP/ISA/AP//
RHMFISS/CJCS WASHINGTON DC//J2/J3/J5//
RHEFDIA/DIA WASHINGTON DC//DHO-3//
RHMFIUU/CDR USPACOM HONOLULU HI//J00/J2/J3/J5//
RHEFAFM/DIRAFMIC FT DETRICK MD//MA-1A//
RUEHSUN/USUN ROME IT

UNCLAS SECTION 01 OF 04 HANOI 000599

SENSITIVE
SIPDIS

STATE FOR EAP/MLS, EAP/EP, INR, OES/STC, OES/IHA, MED
STATE PASS TO USAID FOR ANE AND GH
DEPARTMENT OF DEFENSE FOR OSD/ISA/AP (STERN)
HHS/OSSI/DSI PASS TO FIC/NIH (RGLASS) AND OGHA
(WSTIEGER/LVALDEZ/DMILLER)
USAID FOR ANE (CJENNINGS, MWARD) AND GH (KYAMASHITA, KHILL)
CDC FOR COGH (SBLOUNT), CCID (SREDD) AND DIV-FLU(COX/MOHEN)
USDA PASS TO APHIS, FAS (OSTA AND OCRA), FSIS
BANGKOK FOR RMO, CDC (MMALISON), USAID (MACARTHUR/MBRADY/CBOWES),
APHIS (NCARDENAS), REO (JWALLER)
BEIJING FOR HHS HEALTH ATTACHE (BROSS)
PHNOM PENH FOR CDC INFLUENZA COORDINATOR(WBRADY)
ROME FOR FAO
VIENTIANE FOR CDC INFLUENZA COORDINATOR (ACORWIN)

E.O. 12958: N/A
TAGS: TBIO AMED EAGR PINR KFLU VM
SUBJECT: CLINICAL TRIALS FOR HUMAN AVIAN INFLUENZA VACCINE BEGIN IN
VIETNAM

REF: 07 Hanoi 890

HANOI 00000599 001.2 OF 004


1.(U) Summary. After several years of development, the Government
of Vietnam (GVN) recently initiated a follow-up human clinical trial
for a vaccine against infection with the H5N1 strain of highly
pathogenic avian influenza (HPAI). The trial is ongoing at one of
three national vaccine research and development sites, with trials
expected on different HPAI vaccines at the other two sites in 2009.
The United States Government (USG) has provided financial and
technical assistance to two of the three Vietnamese institutes,
enabling them to produce pilot lots of vaccine strains. USG support
covers development, manufacturing, and scale up of pandemic-like
influenza vaccines, but not the design, participation, nor oversight
of the clinical trials. By 2009, Vietnamese producers hope to have
the capacity to manufacture millions of doses of HPAI vaccines
produced according to international good manufacturing practice
(GMP) standards. This progress is consistent with the long-term
U.S. goal of independent manufacture by Vietnam of vaccines against
seasonal and pandemic influenza. End Summary.

USG Bilateral Support for Vietnamese Human Vaccine Efforts
--------------------------------------------- ---------

2. (SBU) In 2006, the Department of Health and Human Services,
Office of the Assistant Secretary for Preparedness and Response
(ASPR), Biomedical Advanced Research and Development Authority
(BARDA), or herein "HHS," awarded a bilateral grant to the Vaccine
and Bio-technology Products Company No. 1 (VABIOTECH) in Hanoi. HHS
funded VABIOTECH, spun off from the Ministry of Health's National
Institute of Hygiene and Epidemiology (NIHE) and now an
"independent" company, to develop a cell-based human vaccine to
protect against infection with HPAI. [Note: The exact fiscal and
legal separation from NIHE is unclear.] This effort complemented
Korean loan support of about USD 20 million to build a vaccine
manufacturing facility and develop research and production capacity.
Dr. Nguyen Tuyet Nga, the epidemiologist and virologist in charge
of the trial at VABIOTECH, has publicly credited HHS and the WHO for
assistance in project development.

U.S. Funding of WHO Vaccine Assistance in Vietnam
--------------------------------------------- ----

3. (U) In 2007, HHS awarded the World Health Organization (WHO) a
USD 10 million grant to help fund a global project targeting the
development of pandemic influenza vaccines and manufacturing
infrastructure in developing countries. Japan provided an
additional USD 10 million to this initiative, designed (in line with
the Global Vaccine Action Plan of May 2006) to directly include and
leverage the pharmaceutical industry from more developed nations in
the vaccine research and development process and to fill gaps often
seen in the vaccine development pipeline when bringing a product to
market in cooperation with developed countries. A first step was
the award of preparation grants, including USD 25,000 to Vietnam's
Institute of Vaccines and Medical (Biological) Substances (IVAC in
Nha Trang), to support technical assistance to improve the quality
of applications. After the review of the final applications, WHO

HANOI 00000599 002.2 OF 004


awarded funding to six countries, including a USD 2.7 million IVAC
award. The grant covers development, manufacturing, and scale up of
pandemic-like influenza vaccines. After several months of
bureaucratic and bank delays, IVAC had full access to the funds by
the end of April 2008.

VABIOTECH in Hanoi
------------------

4. (SBU) VABIOTECH developed a candidate pre-pandemic HPAI vaccine
derived from the Vietnamese 1194 sub-strain of H5N1 based on
longstanding Vietnamese technology using primary monkey kidney cells
(PMKC). A WHO evaluation team reviewed this candidate vaccine and
preliminary laboratory results in 2006. Although WHO provided
informal recommendations, which included concerns of the possibility
of contamination of the PMKC by an as-of-yet unknown potential human
pathogen, these were never provided officially. VABIOTECH moved
ahead and applied to the MOH to begin trials. Following successful
tests of the locally produced vaccine on mice in 2007, on March 17,
the Department of Science and Training within the Ministry of Health
(MOH) approved two Phase I clinical trials, focusing on vaccine
safety. In early April, VABIOTECH successfully conducted the first
trial on 10 researchers employed directly in the HAPI vaccine
production project.

5. (SBU) In late April, VABIOTECH initiated a second small-scale
Phase I HPAI vaccine trial with 30 student volunteers from the
Military Medical Institute (MMI) in the capital. [Note: This was
reported in the local press. The use of military recruits for
clinical trials presents ethically challenging issues around the
volunterism and autonomy of the subjects]. Injections occured on
May 17 without incident; subjects will be followed for 56 days. A
Phase II trial, expected to begin in June, will include an
additional 240 subjects and will focus on antibody production (as an
immunogenic surrogate of effectiveness), as well as safety.
VABIOTECH's Nga told Michael Perdue, the Deputy Director of the
Division of Influenza and Emerging Diseases, ASPR/BARDA/HHS, that
Vietnam currently plans to produce a seasonal trivalent vaccine (the
industry standard) as well as vaccines specifically targeting H5N1,
using reference influenza strains obtained from National Institute
for Control of Vaccines and Biologicals (NICVB) in the United
Kingdom. Glaxo Smith Kline and another company refused requests from
VABIOTECH to provide reference strains. VABIOTECH has produced over
5,000 doses of seasonal influenza vaccine after receiving
certification from NICVB and expects to produce from two to five
million doses per year by 2009 at USD 2.00 per dose. Further
clinical trials are being planned.

Institute of Vaccines and Medical Biological Substances (IVAC) in
Nha Trang
-------------------

6. (SBU) IVAC is using embryonic chicken eggs (although not ideal,
the egg is the international industry workhorse approach to
influenza vaccine manufacture) to develop a human vaccine candidate
against HPAI also based on a Vietnamese 1194 sub-strain of H5N1.

HANOI 00000599 003.2 OF 004


Though designed to leverage participation from the pharmaceutical
industry of more developed middle-income nations, the program failed
to succesfully engage international private partners, bascially due
to the lack of sufficient mutual, mostly financial, interest. IVAC
has just begun construction of a new purpose built egg-grown vaccine
production facility (including the supporting chicken farm), which
it expects to be complete in early 2009 and which could produce up
to 3 million doses of GMP qualified vaccine. Once it completes the
facility, IVAC plans to conduct clinical trials in human subjects.
IVAC, which recently produced a pilot run of over 5,500 doses of a
human vaccine against HPAI named Fluvac, claimed to have had success
during just completed animal testing. IVAC projects that it will be
able to produce between 500,000 and 3 million doses of Fluvac
vaccine at its new facility each year.

Institute Pasteur in Ho Chi Minh City
-------------------------------------

7. (SBU) Starting work in 2006, the third human vaccine production
site relies on a promising continuous mammalian cell line, Vero
cells, and uses the same strain as IVAC but obtained from the WHO,
an approach also being piloted by several multinational
pharmaceutical companies (not only against HPAI but also targeting
seasonal influenza). Baxter, the proprietary producer of Vero
cells, has received multimillion dollar funding from HHS in 2006 for
seasonal and pandemic influenza vaccine development; this funding
does not touch Vietnam directly. This WHO-approved approach
circumvents problems with egg-based manufacturing (e.g., need for
reliable supply of large number of clean eggs, and human allergy to
egg produced products) but currently the Vero cell process is slower
and lower yields limit large-scale production. HCMC Pasteur, one of
four regional GVN public health and research centers, receives
funding from the Ministry of Science and Technology for the research
and development of Paviflu. For this work, HCMC Pasteur receives
technical assistance from Dr. Kasiryu of Japan but no direct
external funding. Currently in the final stages of the laboratory
aspects of development, HCMC Pasteur plans to file for a GVN license
at the end of this month.

Challenges
----------

8. (U) Each of the Vietnamese human vaccine projects has weaknesses.
Developing an effective HPAI vaccine raises technical challenges
beyond those faced when producing seasonal influenza, including the
deliterious effects of producing vaccine against HPAI on eggs,
HPAI-related health risks to laboratory workers, questions about the
effectiveness of vaccines produced using these new techniques, and
the unproven ability to scale up production during a pandemic. Any
vaccine designed using a current H5N1 strain might not offer
protection against other strains, which could render these
Vietnamese vaccines useless if a pandemic emerges from a strain
sufficiently different than H5N1. To better meet these challenges,
Mission Vietnam has proposed to IVAC, MOH, ASPR/HHS, and WHO a
national conference to review the overall research and development
strategy, to consolidate success, and achieve more robust in-country

HANOI 00000599 004.2 OF 004


coordination.

Comment
-------

9. (SBU) The GVN has taken a practical approach to human vaccine
development, investigating a variety of possible pathways,
recruiting multilateral support and funding, focusing on building
capacity, and fostering an emerging private pharmaceutical industry
for influenza vaccine production. Regardless, and perhaps more
importantly, Vietnam's approach to sharing samples of H5N1 (reftel)
has clearly facilitated the pace and quality of development.
Investment in Vietnam's capacity to produce influenza vaccines,
including seasonal vaccines, satisfies a critical long term pandemic
preparedness goal -- on this count we are on target. For these
reasons, we believe this targeted USG bilateral support and funding
of WHO initiatives has met with success. End Comment.


MICHALAK

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