A phase I/II trial of HIV SF2 gp120/MF59 vaccine in seronegative Thais

Nitayaphan, Sorachai; Khamboonruang, Chirasak; Sirisophana, Narongrid; Morgan, Patricia; Chiu, J. Kam; Duliegè, Anne-Marie; Chuenchitra, Cheodchai; Supapongse, Thippawan; Rungruengthanakit, Kittipong; deSouza, Mark; Mascola, John R.; Boggio, Kit; Ratto‐Kim, Silvia; Markowitz, Lauri E.; Birx, Deborah L.; Suriyanon, Vinai; McNeil, John G.; Brown, Arthur E.; Michael, Rodney A.

doi:10.1016/s0264-410x(99)00421-1

Cited by 63 publications

(43 citation statements)

References 13 publications

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“…MEDI-491, a recombinant parvovirus B19 vaccine formulated with MF59C.1, was found to be safe, well tolerated, and highly immunogenic. Mild-to-moderate pain at the injection site and mild-to-moderate general symptoms, including headache, low-grade fever, gastrointestinal complaints, and fatigue, were reported at rates that were consistent with those reported for other subunit vaccines administered with MF59C.1 [12][13][14]. All subjects in both vaccine dose groups developed virus-neutralizing antibodies that were sustained for at least 6 months after the third dose.…”

supporting

confidence: 71%

Safety and Immunogenicity of a Recombinant Parvovirus B19 Vaccine Formulated with MF59C.1

Ballou¹,

Reed

Noble³

et al. 2003

J INFECT DIS

118

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A recombinant human parvovirus B19 vaccine (MEDI-491; MedImmune) composed of the VP1 and VP2 capsid proteins and formulated with MF59C.1 adjuvant was evaluated in a randomized, double-blind, phase 1 trial. Parvovirus B19-seronegative adults ( ) received either 2.5 or 25 mg n p 24 MEDI-491 at 0, 1, and 6 months. MEDI-491 was safe and immunogenic. All volunteers developed neutralizing antibody titers that peaked after the third immunization and were sustained through study day 364. Parvovirus B19 produces mild, self-limiting illness in immunocompetent, hematologically normal individuals; however, it can cause a variety of more serious conditions, including erythema infectiosum in children, transient aplastic crisis in patients with hemolytic anemia, chronic red blood cell aplasia and anemia in immunodeficient patients, persistent arthropathy in adults, and hydrops fetalis or abortion in pregnant women [1][2][3]. Antiviral drugs are not available for the treatment of parvovirus B19 infection, and no vaccines for the virus are currently approved. The study protocol and informed consent were approved by MDS Harris (Lincoln, NE) and PPD Development (Austin, TX). Informed consent was obtained from all volunteers. The human experimentation guidelines of the US Department of Health and Human Services were followed in conducting the clinical research. A recombinant human parvovirus B19 vaccine (MEDI-491; MedImmune) composed of VP1 and VP2 was expressed in a baculovirus system in which the 2 capsid proteins self-assemble into viruslike particles devoid of viral DNA. Multiple linear neutralizing epitopes are present in the VP1 unique and VP1/ VP2 junction regions. A recombinant peptide corresponding to aa 60-100 of the VP1 unique region, including a sequence with known neutralizing activity, reacted with IgG in 86% of serum samples from human volunteers with documented signs of past B19 infection [4].In a previous study, MEDI-491 formulated with aluminum hydroxide was found to be safe and well tolerated but failed to induce virus-neutralizing antibodies (J. Balsley, unpublished data). Subsequent preclinical studies identified MF59C.1 (Chiron), an oil-in-water emulsion (squalene) in citrate buffer, as a potent adjuvant for MEDI-491 [5]. MF59C.1 adjuvant has been extensively tested in humans [6] and was selected as the adjuvant in the present study.Materials and methods. Parvovirus B19 empty capsid particles consisting of ∼25% VP1 and ∼75% VP2 were produced using a recombinant baculovirus system, as described elsewhere [7]. Surfactant-stabilized emulsion adjuvant (MF59C.1) was supplied by Chiron. MF59C.1 is an oil-in-water formulation that contains surfactants (Tween 80 and Span 85), along with squalene emulsified under high-pressure conditions [8].Twenty-four healthy, parvovirus B19-seronegative adults aged 18-45 years were randomly assigned in a double-blind fashion to receive either 2.5 or 25 mg of MEDI-491 in 0.5 mL of MF59C.1 intramuscularly at 0, 1, and 6 months. Safety was assessed through collection of solicited (days...

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supporting

confidence: 71%

Safety and Immunogenicity of a Recombinant Parvovirus B19 Vaccine Formulated with MF59C.1

Ballou¹,

Reed

Noble³

et al. 2003

J INFECT DIS

118

View full text Add to dashboard Cite

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“…Prior attempts using an Env glycoprotein-based vaccine design have been hampered either by poor immunogenicity (1) or by the lack of an antibody response that can effectively neutralize several circulating strains of HIV (56). This result may be due partly to the use of recombinant Env glycoproteins based on a single viral isolate (38,40,47,52,59). Attempts at vaccinating with recombinant viral vectors encoding Env glycoprotein and boosting with gp120 recombinant proteins have not been successful in generating broadly reactive antibodies capable of neutralizing primary viral isolates (35).…”

mentioning

confidence: 99%

Multifunctional T-Cell Characteristics Induced by a Polyvalent DNA Prime/Protein Boost Human Immunodeficiency Virus Type 1 Vaccine Regimen Given to Healthy Adults Are Dependent on the Route and Dose of Administration

Bansal

Jackson²,

West

et al. 2008

J Virol

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“…Since 1992, antiretroviral medication has been provided for HIV-infected personnel and AIDS patients in the RTA medical facilities. [25][26][27] In 1991, the AFRIMS, in cooperation with Walter Reed Army Institute of Research, USA, started a project to conduct research on HIV/AIDS in the areas of epidemiology, virology and HIV/AIDS vaccine development, with an understanding that AFRIMS would concurrently receive assistance for personnel and infrastructure development. AFRIMS, in collaboration with the US Army, took a leading role in AIDS vaccine development in Thailand.…”

Section: Role Of the Rta In Providing Care And Support To Pwamentioning

confidence: 99%

The uses of epidemiologic and public health approaches for HIV/AIDS control among young men in the Royal Thai Army and Thailand

Saengdidtha¹,

Rangsin

Kana

et al. 2012

Sanid. Mil.

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SUMMARYThe effectiveness of HIV/AIDS control in Thailand is well recognized internationally and is due to the perception of national threat, the acknowledgement of the policy-makers, the efficient mechanisms of management at all levels, the relevant counter-measures and plans, the sustained commitment in the fight against HIV/AIDS and the total mobilization of all sectors of the country to deal with the problems. The Royal Thai Army (RTA) and the RTA Medical Department (RTAMD) have significant roles in solving the HIV/AIDS problems by partnering in the threat assessment, surveillance among conscripts to monitor HIV spread and control it effectively, research on behavioral risks leading to the development of targeted intervention models first piloted with conscripts and later adapted for other risk groups, providing care and support to people living with HIV/AIDS (PWA) and cooperation with civilian and international partners. Factors that have contributed to the success of the RTA's operations include the strong organizational infrastructure and management, the relevant strategies and measures, the determination for long-term commitment and total mobilization of resources and multi-sectoral coordination. The lessons learned from the RTA's experience in HIV/AIDS prevention and impact alleviation, especially by epidemiologic and public health approaches, can be used as a basis for further development towards more effective and efficient models. It can also be a useful example for other agencies in Thailand and other countries with the same problems and similar socio-cultural backgrounds to apply and adapt for their own uses.KEY WORDS: HIV/AIDS, Thailand, Public health, Epidemiology, Royal Thai Army, Young men.Actuaciones epidemiológicas y de salud pública para el control del VIH / SIDA entre los hombres jóvenes en Tailandia y el Real Ejército de Tailandia RESUMEN La eficacia del control del VIH/SIDA en Tailandia es bien conocida a nivel internacional y se debe a la percepción de amenaza nacional, el reconocimiento de los encargados de formular las medidas políticas a adoptar, los mecanismos eficientes de gestión a todos los niveles, las correspondientes contramedidas y planes, el desarrollo sostenido del compromiso en la lucha contra el VIH/SIDA y la movilización total de todos los sectores del país para hacer frente a este problema. El Ejército Real Tailandés (RTA) y el Departamento Médico del RTA (RTAMD) han desarrollado un papel importante en la solución de los problemas del VIH/SIDA mediante la evaluación de la amenaza, la vigilancia sobre los soldados para controlar la propagación del VIH y su control de manera efectiva, la investigación sobre comportamientos de riesgo, que propicien al desarrollo de modelos de intervención, dirigidos primero a los soldados y más tarde adaptado para otros grupos de riesgo, proporcionando atención y apoyo a las personas que viven con el VIH/ SIDA (PVVS) y la cooperación con entiddaes civiles e internacionales. Los factores que han contribuido al éxito de las operaciones de la R...

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A phase I/II trial of HIV SF2 gp120/MF59 vaccine in seronegative Thais

Cited by 63 publications

References 13 publications

Safety and Immunogenicity of a Recombinant Parvovirus B19 Vaccine Formulated with MF59C.1

Safety and Immunogenicity of a Recombinant Parvovirus B19 Vaccine Formulated with MF59C.1

Multifunctional T-Cell Characteristics Induced by a Polyvalent DNA Prime/Protein Boost Human Immunodeficiency Virus Type 1 Vaccine Regimen Given to Healthy Adults Are Dependent on the Route and Dose of Administration

The uses of epidemiologic and public health approaches for HIV/AIDS control among young men in the Royal Thai Army and Thailand

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