Tuberculosis Vaccine Research

Tuberculosis (TB) kills more than 1.5 million people each year and more than on fourth of the worlds population is infected with the bacterium. Drug resistant TB strains are spreading with alarming speed and mass vaccination with the current vaccine has not been able to control the epidemic. Statens Serum Institut is one of the leading institutions in the international efforts to develop a new, safe and effective vaccine.

Tuberculosis vaccine research at SSI

Tuberculosis (TB) is one of the oldest known human diseases and is caused by inhalation of the bacterium Mycobacterium tuberculosis (Mtb). It is a slow progressing chronic disease and infected individuals are often life-long carriers of the bacteria. Despite progress in the availability of effective antibiotic treatment, Mtb remains the most deadly human pathogen and drug resistant Mtb-strains are causing an increasing number of TB cases.

Bacillus Calmette-Guérin (BCG) is the only licensed TB vaccine and is effective against severe forms of TB in children. However, it does not control pulmonary TB in adults and adolescents that are the primary disease transmitters. Also, BCG does not protect the billions of people that are already and it is evident that a new vaccine is needed to combat the global epidemic.

The research at SSI is focused on the interactions between pathogen and host. Using samples from patients and advanced animal models we identify mechanisms in the immune system that most efficiently combat the bacteria and use this knowledge to design and test new vaccine concepts targeting different aspects of disease.

Our goal is to deliver safe and efficacious vaccines that protect individuals before they are infected as well as protect the many people that already are infection from progressing to active disease. We have developed three different vaccines that have already entered clinical testing and we are currently working on an improved next-generation vaccine based on the most recent scientific advances. We are also pioneering research focused on therapeutic vaccination with the overall goal of using new TB vaccines to improve treatment regimens for drug resistant TB.

Research projects


POR TB Consortium

Title: POR TB Consortium; Phase 2 trial to determine efficacy of the multistage vaccine H56:IC31 for Prevention of Recurrent TB disease

Objective: The project aims 1) to accelerate the clinical development of the leading TB vaccine candidate (H56:IC31) by conducting a phase 2 prevention of recurrent TB vaccine trial 2) to support capacity Development to expand TB vaccine clinical trial and Laboratory expertise in Sub-saharan Africa 3) to advance understanding of mechanisms of reactogenisity, immunogenicity and efficacy

Participants: The Aurum Institute, South Africa; Ospedale San Raffaele, Italy; University of Cape Town, SATVI, South Africa; Task Foundation NPC, South Africa; University of Cape Town, Lung Institute, South Africa; National Institute of Medical Research - Tanzania (NIMR); Areas Global Tuberculosis Foundation NPC, South Africa and Statens Serum Institut (SSI), Denmark

Funded by: The European & Developing Countries Clinical Trials Partnership (EDCTP)

EDCTP logoPOR Consortium logo

Contact: Kjersti Moen, Solveig Walløe, Rasmus S. Mortensen,

A dual function TB subunit vaccine

Title: A dual function TB subunit vaccine designed for non-interference with BCG and post-exposure activity

Objective: The project aims to perform molecular modifications of a family of new vaccine candidates in order to enhance immunogenicity in vivo in preventive and post-exposure settings. Further the project will evaluate the modified vaccines in multiple novel advanced animal models of post-Mtb exposure and develop a GMP product towards clinical trial progression of the best vaccine candidate.

Participants: Staten Serum Institut (SSI,Denmark), Center for Infectious Disease Research (CIDR, USA), Public Health England (PHE)

Funded by: National Institutes of Health (NIH), USA

National Institutes of Health logo

Contact: Rasmus Skaarup Mortensen,

Eliciting lung-localized CD4 T cell responses against Mtb

Title: Eliciting lung-localized CD4 T cell responses against Mycobacterium tuberculosis in preventive and post-exposure settings

Objective: The project aims to elucidate basic mechanisms for how CD4 T cells can migrate into the lung tissue, how they are positioned relative to the infected areas (granulomas) and how they can be retained once there as well as be refractory to functional exhaustion during the chronic / latent phase of the infection. In addition, the project aims to develop vaccination strategies that optimally prime such protective CD4 T cells, regardless of previous exposure status to Mtb.

Participants: Center for Infectious Disease Research (CIDR) USA, Statens Serum Institut (SSI) Denmark University of Cape Town/SATVI, South Africa

Funded by: National Institutes of Health (NIH), USA

National Institutes of Health logo

Contact: Thomas Lindenstrøm,

Rasmus Skaarup Mortensen


Rasmus Skaarup Mortensen , Infektionsimmunologi / TB Vaccine
T. +45 32688309 @. View profile