HIV Infected Children not to be given BCG Vaccine.

Revised BCG vaccination guidelines for infants at risk for HIV infection

Following a review of relevant data, the Global Advisory Committee on Vaccine Safety (GACVS) has revised its previous recommendations concerning bacille Calmette1 Guerin (BCG) vaccination of children infected with the human immunodeficiency virus (HIV).

WHO had previously recommended that in countries with a high burden of tuberculosis (TB), a single dose of BCG vaccine should be given to all healthy infants as soon as possible after birth, unless the child presented with symptomatic HIV infection.

However, recent evidence shows that children who were HIV-infected when vaccinated with BCG at birth, and who later developed AIDS, were at increased risk of developing disseminated BCG disease. Among these children, the benefits of potentially preventing severe TB are outweighed by the risks associated with the use of BCG vaccine.

GACVS therefore advised WHO to change its recommendation such that children who are known to be HIV-infected, even if asymptomatic, should no longer be immunized with BCG vaccine.

Dr Diwakar Tejaswi
MBBS(Gold Medalist); MCH; FCCP; Ph.D
Consultant Physician and Medical Director
RATNEI, IHO
Medical Advisor- Public Awareness for Healthful Approach for Living (PAHAL)
Harinarayan Complex, Exhibition Road, Patna 800001, India

Safety of BCG vaccine in HIV-infected children

The committee has reviewed the policy on the use of bacille Calmette–Guérin (BCG) vaccination for children infected with HIV. Data from retrospective studies from Argentina and South Africa indicate there is a substantiated higher risk of disseminated BCG disease developing in children infected with HIV who are vaccinated at birth and who later developed AIDS. The reported risk associated with vaccinating HIV-infected children may outweigh the benefits of preventing severe tuberculosis, especially since the protective effect of BCG against tuberculosis in HIV-infected children is not known.

WHO currently recommends administering a single dose of BCG vaccine to all infants living in areas where tuberculosis is highly endemic as well as to infants and children at particular risk of exposure to tuberculosis in countries with low endemicity. BCG vaccine is contraindicated in people with impaired immunity, and WHO does not recommend BCG vaccination for children with symptomatic HIV infection.

GACVS concluded that the findings indicated there is a high risk of disseminated BCG disease developing in HIV-infected infants and therefore BCG vaccine should not be used in children who are known to be HIV infected.

The committee recognizes the difficulty in identifying infants infected with HIV at birth in settings where diagnostic and treatment services for mothers and infants are limited. In such situations, BCG vaccination should continue to be given at birth to all infants regardless of HIV exposure, especially considering the high endemicity of tuberculosis in populations with high HIV prevalence. Close follow up of infants known to be born to HIV-infected mothers and who received BCG at birth is recommended in order to provide early identification and treatment of any BCG-related complication. In settings with adequate HIV services that could allow for early identification and administration of antiretroviral therapy to HIV-infected children, consideration should be given to delaying BCG vaccination in infants born to mothers known to be infected with HIV until these infants are confirmed to be HIV negative.

Published in the WHO Weekly Epidemiological Record on 19 January 2007

Page last reviewed: 3 December 2008

 

http://www.who.int/vaccine_safety/topics/bcg/immunocompromised/Dec_2006/en/index.html

BCG vaccination may not benefit HIV-infected infants, suggest SATVI studies http://www.satvi.uct.ac.za/news/bcg-vaccination-does-not-benefit-hiv-infected-infants-suggest-satvi-studies.html Print
5 January 2009, Cape Town - Two studies by the South African Tuberculosis Vaccine Initiative (SATVI) of the University of Cape Town (UCT), and accepted for publication in The Journal of Infectious Diseases and Clinical Immunology, show data that strongly support not giving BCG to HIV-infected infants.

The studies demonstrate that HIV infection severely impairs BCG-specific as well as other T cell immunity during the first year of life, and the authors conclude that BCG vaccination may therefore provide little, if any, vaccine-induced benefit in HIV-infected infants.

These studies form part of multiple studies by SATVI aimed at evaluating the risks and benefits of BCG vaccination in HIV-infected infants.

"Currently, almost all HIV exposed children from developing countries with high prevalence of tuberculosis (TB) disease receive BCG soon after birth", says Professor Gregory Hussey, Director of SATVI. "Because tuberculosis is a common cause of death of HIV-infected infants, the vaccine should be given if it works. However, we do not know whether BCG does protect HIV-infected children against TB disease; rather BCG may itself cause disease (termed BCGosis) in this susceptible population. SATVI therefore wanted to determine the effects of HIV-infection and HIV exposure (HIV-negative infants born to HIV-infected mothers) on the BCG-induced immune response."

Three groups of infants were recruited into the study, namely HIV-positive, exposed HIV-, and HIV-unexposed infants. Blood was collected at 3, 6, 9 and 12 months of age.

The study results show that whilst BCG vaccination of the 2 HIV-uninfected groups induced a robust immune response, HIV-infected infants had a markedly lower response throughout the first year of life. These infants also had significantly reduced numbers of polyfunctional CD4 T cells, which simultaneously express the cytokines IFN-g, TNF-a and IL-2, and are thought to indicate a cell population that protects against TB. No differences were detected between HIV-exposed and unexposed uninfected infants.

In a substudy, the changes in total CD4 and CD8 T cells expressing memory and activation markers were also evaluated over the first year of life. In HIV-infected infants, the frequency of naive CD8 T cells was significantly decreased, while the frequency of effector memory CD8 T cells was increased, compared with the two uninfected control groups.Differences in CD4 T cell subsets were less pronounced, and again no significant differences were observed between exposed and unexposed HIV-uninfected infants.

 

 

Links to articles published in The Journal of Infectious Diseases and Clinical Immunology:

Mansoor N, Scriba TJ, de Kock M, Tameris M, Abel B, Keyser A, Little F, Soares A, Gelderbloem S, Mlenjeni S, Denation L, Hawkridge A, Boom WH, Kaplan G, Hussey GD, Hanekom WA. Infant HIV-1 Infection Severely Impairs the Bacille Calmette-Guerin Vaccine-Induced Immune Response. In press, The Journal of Infectious Diseases

Mansoor N, Abel B, Scriba TJ, Hughes J, de Kock M, Tameris M, Mlenjeni S, Denation L, Little F, Gelderbloem S, Hawkridge A, Boom WH, Kaplan G, Hussey GD, Hanekom WA. Significantly skewed memory CD8(+) T cell subsets in HIV-1 infected infants during the first year of life. In press, Clinical Immunology.

TB vaccine sickens HIV-infected children - report

Fri Nov 2, 2007 8:27pm GMT
By Maggie Fox, Health and Science Editor

WASHINGTON, Nov 2 (Reuters) - A vaccine aimed at protecting children in developing countries from deadly tuberculosis may be killing and sickening some vulnerable infants infected with the AIDS virus, researchers said on Friday.

They said the Bacille Calmette-Guerin or BCG vaccine, which is made using a bovine version of tuberculosis, appeared to be causing serious infections in some babies and young children who are HIV-infected.

"One study found a 75-percent mortality rate in children with BCG disease, and 70 percent of those children were HIV-infected. Clearly, this is a problem in need of immediate attention," said Dr. Mark Cotton, a pediatrician and HIV researcher at Stellenbosch University in South Africa.

Cotton's findings are part of a report issued on Friday about the health emergency caused globally by the double whammy of HIV and TB.

The AIDS virus destroys the immune system, and tuberculosis has made a return globally because of this. Usually a latent infection, activated TB can kill quickly.

"Now the eye of the storm is in sub-Saharan Africa, where half of new TB cases are HIV co-infected, and where drug-resistant TB is silently spreading," said Veronica Miller, director of The Forum for Collaborative HIV Research, a global independent public-private group that includes researchers, patient advocates, and government and industry.

"It is here now. But the science and coordination needed to stop it are utterly insufficient."

The human immunodeficiency virus infects an estimated 40 million people globally. There is no cure and when untreated, it steadily destroys the immune system. Patients are vulnerable to a range of infections including TB.

BILLIONS INFECTED

TB infects one-third of the world's population. Without proper treatment, 90 percent of people infected with both die within months.

Usually, tuberculosis only becomes an active infection in one out of 10 people over a lifetime. But 10 percent of HIV patients who also have TB develop activated tuberculosis every year.

The BCG vaccine is given at birth in most developing countries. But because it uses a live microbe, in people with weakened immune systems it can itself cause disease.

"It is especially a problem where they have delayed access to diagnosis of HIV or delayed access to antiretroviral therapy," Cotton said in a telephone interview.

"It also is quite hard to diagnose it," he added. "We don't know how widespread it is across Africa."

Cotton said an estimated 400 per 100,000 HIV-infected infants in the Western Cape of South Africa had become sick from the BCG vaccine.

"The problem is the vaccine is usually given within the first few days of life," Cotton said. But babies are not tested for HIV infection until about 6 weeks of age, meaning many infants are unknowingly being given a vaccine that is dangerous for them.

Cotton said it might be possible to simply vaccinate children with BCG after it is known whether they are HIV-infected.

"But once you interfere with a program and make it a bit complicated, it can have repercussions as well, so it is a bit of a dilemma," he said.

The best result would be to have earlier diagnosis and treatment of HIV. Children infected with HIV can be given an antibiotic, isoniazid, to prevent TB infection, Cotton said.